MAHURKAR recallZ-1320-2022 · Covidien Llc · initiated Jun 8, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Covidien Llc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.
FDA root cause category: Process control
What the company is doing
Medtronic distributed a recall notification to customers by mail on 06/08/2022. Customers were instructed to immediately quarantine and discontinue use for specific lots of chronic hemodialysis catheters, which are to be returned to Medtronic. If customers have further distributed product, they are asked to forward the information from the recall notification to those recipients. All customers are asked to complete and return the Consignee Product Retrieval Confirmation Form to [email protected]. Additionally, consignees are asked to share the notice within their organization and retain it for their records regarding the retrieval of unused product. If a consignee is aware of any adverse events associated with recalled product, they are to submit a report to FDA via Medwatch. Customers with any questions can contact their Medtronic Representative or call Customer Service at 800-962-9888, option 2. ***Updated 8/16/22*** Medtronic has created a website to help customers identify affected product: https://www.medtronic.com/covidien/en-us/products/c/renal-care-recall-lookup-tool.html#lotLookupTool
Recall details
- Recall number
- Z-1320-2022
- Status
- Open, Classified
- Initiated by the company
- Jun 8, 2022
- Posted by the FDA
- Jul 7, 2022
- Recalling firm
- Covidien Llc
- Quantity
- 132,443 units
- Product code
- MSD
- FDA submissions
- K111372
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, DC, GU, & PR. The countries of Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Botswana, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Faroe Islands, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Islamic Republic of Iran, Ireland, Israel, Italy, Jamaica, Japan, Kenya, Republic of Korea, Kosovo, Kuwait, Lebanon, Luxembourg, Macao, Malaysia, Maldives, Malta, Mayotte, Mexico, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, North Macedonia, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Senegal, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Trinidad And Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, United States, Viet Nam, Virgin Islands, and Zimbabwe.
Product description
Mahurkar Chronic Carbothane (Maxid) Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
Code information (models, lots, serial numbers)
Show the full code information (20k characters)
Code Information organized as "Model No., Serial No., GTIN": 8888119362, 1928800230, 10884521056879; 8888119362, 1825400094, 20884521056876; 8888119362, 1912600107, 20884521056876; 8888119362, 1917600139, 20884521056876; 8888119362, 1917700080, 20884521056876; 8888119362, 1925200098, 20884521056876; 8888119362, 1927300146, 20884521056876; 8888119362, 1928800230, 20884521056876; 8888119362, 2023300144, 20884521056876; 8888119362, 2028200216, 20884521056876; 8888119362, 2122900239, 20884521056876; 8888119385, 1720700105, 20884521012421; 8888119385, 1724900109, 20884521012421; 8888119385, 2113300429, 20884521012421; 8888123402, 1927500121, 10884521056886; 8888123402, 2028200203, 10884521056886; 8888123402, 2110900059, 10884521056886; 8888123402, 1921700145, 20884521056883; 8888123402, 1924000138, 20884521056883; 8888123402, 1925200091, 20884521056883; 8888123402, 1927500120, 20884521056883; 8888123402, 1927500121, 20884521056883; 8888123402, 2023300143, 20884521056883; 8888123402, 2026000055, 20884521056883; 8888123402, 2028200203, 20884521056883; 8888123402, 2034400155, 20884521056883; 8888123402, 2104100105, 20884521056883; 8888123402, 2110900059, 20884521056883; 8888123402, 2113300432, 20884521056883; 8888123402, 2122900252, 20884521056883; 8888123435, 2034400156, 10884521012516; 8888123435, 1716500170, 20884521012513; 8888123435, 1716700115, 20884521012513; 8888123435, 1825400095, 20884521012513; 8888123435, 1831000101, 20884521012513; 8888123435, 2003700038, 20884521012513; 8888123435, 2034400156, 20884521012513; 8888123435, 2106900231, 20884521012513; 8888123435, 2113300430, 20884521012513; 8888128452, 2023300145, 10884521056916; 8888128452, 1716500171, 20884521056913; 8888128452, 1831000102, 20884521056913; 8888128452, 1904200079, 20884521056913; 8888128452, 2023300145, 20884521056913; 8888128485, 1716500172, 20884521012544; 8888128485, 1718600097, 20884521012544; 8888128485, 1720000119, 20884521012544; 8888133502, 1715100148, 20884521056920; 8888133535, 1924000139, 20884521013947; 8888145001, 1715800112, 10884521014084; 8888145001, 1722300112, 10884521014084; 8888145001, 1722600094, 10884521014084; 8888145001, 1723400093, 10884521014084; 8888145001, 1831000103, 10884521014084; 8888145001, 1904900119, 10884521014084; 8888145001, 1910200086, 10884521014084; 8888145001, 1912600085, 10884521014084; 8888145001, 1919700113, 10884521014084; 8888145001, 1925200099, 10884521014084; 8888145001, 2003700040, 10884521014084; 8888145001, 2008400137, 10884521014084; 8888145001, 2014900153, 10884521014084; 8888145001, 2014900166, 10884521014084; 8888145001, 2017500086, 10884521014084; 8888145001, 2017600091, 10884521014084; 8888145001, 2017600092, 10884521014084; 8888145001, 2017800060, 10884521014084; 8888145001, 1715300102, 20884521014081; 8888145001, 1715800112, 20884521014081; 8888145001, 1717200147, 20884521014081; 8888145001, 1717900143, 20884521014081; 8888145001, 1719300092, 20884521014081; 8888145001, 1720700107, 20884521014081; 8888145001, 1721300152, 20884521014081; 8888145001, 1722100148, 20884521014081; 8888145001, 1722300110, 20884521014081; 8888145001, 1722300111, 20884521014081; 8888145001, 1722300112, 20884521014081; 8888145001, 1722600094, 20884521014081; 8888145001, 1723400093, 20884521014081; 8888145001, 1723400094, 20884521014081; 8888145001, 1729100101, 20884521014081; 8888145001, 1810000171, 20884521014081; 8888145001, 1811500160, 20884521014081; 8888145001, 1827600114, 20884521014081; 8888145001, 1828200109, 20884521014081; 8888145001, 1829500106, 20884521014081; 8888145001, 1831000103, 20884521014081; 8888145001, 1834500194, 20884521014081; 8888145001, 1904200086, 20884521014081; 8888145001, 1904900119, 20884521014081; 8888145001, 1904900120, 20884521014081; 8888145001, 1905600120, 20884521014081; 8888145001, 1905600121, 20884521014081; 8888145001, 1906000118, 20884521014081; 8888145001, 1906000119, 20884521014081; 8888145001, 1910200086, 20884521014081; 8888145001, 1910200087, 20884521014081; 8888145001, 1910600255, 20884521014081; 8888145001, 1910600258, 20884521014081; 8888145001, 1912600085, 20884521014081; 8888145001, 1912600086, 20884521014081; 8888145001, 1919700113, 20884521014081; 8888145001, 1924000150, 20884521014081; 8888145001, 1925200099, 20884521014081; 8888145001, 2003700040, 20884521014081; 8888145001, 2008400137, 20884521014081; 8888145001, 2014900153, 20884521014081; 8888145001, 2014900164, 20884521014081; 8888145001, 2014900166, 20884521014081; 8888145001, 2014900167, 20884521014081; 8888145001, 2014900168, 20884521014081; 8888145001, 2014900169, 20884521014081; 8888145001, 2015300068, 20884521014081; 8888145001, 2017500086, 20884521014081; 8888145001, 2017600091, 20884521014081; 8888145001, 2017600092, 20884521014081; 8888145001, 2017800060, 20884521014081; 8888145001, 2124600201, 20884521014081; 8888145002, 1833100106, 10884521014145; 8888145002, 1914800162, 10884521014145; 8888145002, 1914800164, 10884521014145; 8888145002, 1920700130, 10884521014145; 8888145002, 2009300119, 10884521014145; 8888145002, 2027200195, 10884521014145; 8888145002, 2027200206, 10884521014145; 8888145002, 2034300098, 10884521014145; 8888145002, 1725100109, 20884521014142; 8888145002, 1728400115, 20884521014142; 8888145002, 1731200161, 20884521014142; 8888145002, 1732600137, 20884521014142; 8888145002, 1831600193, 20884521014142; 8888145002, 1833100106, 20884521014142; 8888145002, 1833800130, 20884521014142; 8888145002, 1906700180, 20884521014142; 8888145002, 1914400129, 20884521014142; 8888145002, 1914800162, 20884521014142; 8888145002, 1914800164, 20884521014142; 8888145002, 1917600065, 20884521014142; 8888145002, 1920700130, 20884521014142; 8888145002, 2009300119, 20884521014142; 8888145002, 2027200195, 20884521014142; 8888145002, 2027200206, 20884521014142; 8888145002, 2034300098, 20884521014142; 8888145003, 1727700140, 20884521014180; 8888145003, 1828900129, 20884521014180; 8888145003, 2001400108, 20884521014180; 8888145004, 1715100150, 20884521014203; 8888145004, 1725500097, 20884521014203; 8888145004, 1801000133, 20884521014203; 8888145027, 1720700106, 10884521056930; 8888145027, 1726300133, 10884521056930; 8888145027, 1805200080, 10884521056930; 8888145027, 1814300195, 10884521056930; 8888145027, 1822000073, 10884521056930; 8888145027, 1830300164, 10884521056930; 8888145027, 1926100268, 10884521056930; 8888145027, 1830300164, 20884521056937; 8888145027, 1916500080, 20884521056937; 8888145027, 1926100268, 20884521056937; 8888145027, 2003700043, 20884521056937; 8888145027, 2009300081, 20884521056937; 8888145027, 2026000074, 20884521056937; 8888145027, 2027300039, 20884521056937; 8888145027, 2034400151, 20884521056937; 8888145027, 2102500099, 20884521056937; 8888145027, 2104600166, 20884521056937; 8888145028, 1728400117, 10884521056947; 8888145028, 1805200081, 10884521056947; 8888145028, 1834500198, 10884521056947; 8888145028, 2034400152, 10884521056947; 8888145028, 2102500100, 10884521056947; 8888145028, 1834500198, 20884521056944; 8888145028, 1917600137, 20884521056944; 8888145028, 2002100143, 20884521056944; 8888145028, 2023300108, 20884521056944; 8888145028, 2031800136, 20884521056944; 8888145028, 2034400152, 20884521056944; 8888145028, 2102500100, 20884521056944; 8888145028, 2124600209, 20884521056944; 8888145029, 2031800133, 20884521056951; 8888145029, 2034400153, 20884521056951; 8888145030, 1729700114, 20884521056968; 8888145251, 1715100151, 10884521014220; 8888145251, 1715800113, 10884521014220; 8888145251, 1716500173, 10884521014220; 8888145251, 1717500004, 10884521014220; 8888145251, 1717900144, 10884521014220; 8888145251, 1718600098, 10884521014220; 8888145251, 1719300093, 10884521014220; 8888145251, 1720000120, 10884521014220; 8888145251, 1720700108, 10884521014220; 8888145251, 1721300153, 10884521014220; 8888145251, 1723400095, 10884521014220; 8888145251, 1727100080, 10884521014220; 8888145251, 1727700141, 10884521014220; 8888145251, 1731900229, 10884521014220; 8888145251, 1732600131, 10884521014220; 8888145251, 1733300154, 10884521014220; 8888145251, 1733700133, 10884521014220; 8888145251, 1733700188, 10884521014220; 8888145251, 1734700109, 10884521014220; 8888145251, 1800300132, 10884521014220; 8888145251, 1800300140, 10884521014220; 8888145251, 1805200106, 10884521014220; 8888145251, 1806600084, 10884521014220; 8888145251, 1808600071, 10884521014220; 8888145251, 1812900138, 10884521014220; 8888145251, 1812900139, 10884521014220; 8888145251, 1814600080, 10884521014220; 8888145251, 1827600117, 10884521014220; 8888145251, 1827600118, 10884521014220; 8888145251, 1831600195, 10884521014220; 8888145251, 1831600196, 10884521014220; 8888145251, 1833800140, 10884521014220; 8888145251, 1834500196, 10884521014220; 8888145251, 1834500206, 10884521014220; 8888145251, 1835100102, 10884521014220; 8888145251, 1835300203, 10884521014220; 8888145251, 1913000094, 10884521014220; 8888145251, 1914000293, 10884521014220; 8888145251, 1914000294, 10884521014220; 8888145251, 1914400122, 10884521014220; 8888145251, 1916500098, 10884521014220; 8888145251, 1916500099, 10884521014220; 8888145251, 1916500100, 10884521014220; 8888145251, 1926100264, 10884521014220; 8888145251, 1926100265, 10884521014220; 8888145251, 1926100266, 10884521014220; 8888145251, 1934400191, 10884521014220; 8888145251, 1934400192, 10884521014220; 8888145251, 2002100144, 10884521014220; 8888145251, 2014900172, 10884521014220; 8888145251, 2017500089, 10884521014220; 8888145251, 2017500132, 10884521014220; 8888145251, 2017500137, 10884521014220; 8888145251, 2019500267, 10884521014220; 8888145251, 2021000067, 10884521014220; 8888145251, 2021000068, 10884521014220; 8888145251, 2023300104, 10884521014220; 8888145251, 2034400176, 10884521014220; 8888145251, 2106900163, 10884521014220; 8888145251, 2106900204, 10884521014220; 8888145251, 2113300431, 10884521014220; 8888145251, 1715100151, 20884521014227; 8888145251, 1715800113, 20884521014227; 8888145251, 1716500173, 20884521014227; 8888145251, 1717500004, 20884521014227; 8888145251, 1717900144, 20884521014227; 8888145251, 1718600098, 20884521014227; 8888145251, 1719300093, 20884521014227; 8888145251, 1720000120, 20884521014227; 8888145251, 1720700108, 20884521014227; 8888145251, 1721300153, 20884521014227; 8888145251, 1723400095, 20884521014227; 8888145251, 1727100080, 20884521014227; 8888145251, 1727700141, 20884521014227; 8888145251, 1731900229, 20884521014227; 8888145251, 1732600131, 20884521014227; 8888145251, 1733300154, 20884521014227; 8888145251, 1733700133, 20884521014227; 8888145251, 1733700188, 20884521014227; 8888145251, 1734700109, 20884521014227; 8888145251, 1800300132, 20884521014227; 8888145251, 1800300140, 20884521014227; 8888145251, 1805200106, 20884521014227; 8888145251, 1806600084, 20884521014227; 8888145251, 1808600071, 20884521014227; 8888145251, 1812900138, 20884521014227; 8888145251, 1812900139, 20884521014227; 8888145251, 1814600080, 20884521014227; 8888145251, 1827600117, 20884521014227; 8888145251, 1827600118, 20884521014227; 8888145251, 1831600195, 20884521014227; 8888145251, 1831600196, 20884521014227; 8888145251, 1834500206, 20884521014227; 8888145251, 1835100102, 20884521014227; 8888145251, 1835300203, 20884521014227; 8888145251, 1913000094, 20884521014227; 8888145251, 1914000293, 20884521014227; 8888145251, 1914000294, 20884521014227; 8888145251, 1914400122, 20884521014227; 8888145251, 1914400123, 20884521014227; 8888145251, 1916500098, 20884521014227; 8888145251, 1916500099, 20884521014227; 8888145251, 1916500100, 20884521014227; 8888145251, 1926100264, 20884521014227; 8888145251, 1926100265, 20884521014227; 8888145251, 1926100266, 20884521014227; 8888145251, 1934400191, 20884521014227; 8888145251, 1934400192, 20884521014227; 8888145251, 2002100144, 20884521014227; 8888145251, 2008400141, 20884521014227; 8888145251, 2014900158, 20884521014227; 8888145251, 2014900172, 20884521014227; 8888145251, 2017500089, 20884521014227; 8888145251, 2017500132, 20884521014227; 8888145251, 2017500137, 20884521014227; 8888145251, 2019500267, 20884521014227; 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8888145252, 1908400301, 10884521014244; 8888145252, 1913000179, 10884521014244; 8888145252, 1913000180, 10884521014244; 8888145252, 1913000181, 10884521014244; 8888145252, 1914000241, 10884521014244; 8888145252, 1914800206, 10884521014244; 8888145252, 1915800101, 10884521014244; 8888145252, 1917200226, 10884521014244; 8888145252, 1935100108, 10884521014244; 8888145252, 1935100109, 10884521014244; 8888145252, 2002900149, 10884521014244; 8888145252, 2009300077, 10884521014244; 8888145252, 2014900160, 10884521014244; 8888145252, 2015400078, 10884521014244; 8888145252, 2019500178, 10884521014244; 8888145252, 2019500270, 10884521014244; 8888145252, 2020400103, 10884521014244; 8888145252, 2020400104, 10884521014244; 8888145252, 2023300107, 10884521014244; 8888145252, 2027200208, 10884521014244; 8888145252, 2028000088, 10884521014244; 8888145252, 2030300103, 10884521014244; 8888145252, 2034400173, 10884521014244; 8888145252, 2104600208, 10884521014244; 8888145252, 2104600211, 10884521014244; 8888145252, 2104800077, 10884521014244; 8888145252, 2106900104, 10884521014244; 8888145252, 1717900145, 20884521014241; 8888145252, 1719300094, 20884521014241; 8888145252, 1720000121, 20884521014241; 8888145252, 1720700109, 20884521014241; 8888145252, 1721300168, 20884521014241; 8888145252, 1724300117, 20884521014241; 8888145252, 1727700139, 20884521014241; 8888145252, 1728400118, 20884521014241; 8888145252, 1800400103, 20884521014241; 8888145252, 1801700129, 20884521014241; 8888145252, 1805900114, 20884521014241; 8888145252, 1805900133, 20884521014241; 8888145252, 1806600083, 20884521014241; 8888145252, 1807300175, 20884521014241; 8888145252, 1808600069, 20884521014241; 8888145252, 1811500157, 20884521014241; 8888145252, 1813600094, 20884521014241; 8888145252, 1817100080, 20884521014241; 8888145252, 1826200167, 20884521014241; 8888145252, 1826800153, 20884521014241; 8888145252, 1828200107, 20884521014241; 8888145252, 1828200108, 20884521014241; 8888145252, 1828900140, 20884521014241; 8888145252, 1829500126, 20884521014241; 8888145252, 1830300140, 20884521014241; 8888145252, 1832300104, 20884521014241; 8888145252, 1832300105, 20884521014241; 8888145252, 1833100107, 20884521014241; 8888145252, 1833800142, 20884521014241; 8888145252, 1907800085, 20884521014241; 8888145252, 1908400301, 20884521014241; 8888145252, 1913000179, 20884521014241; 8888145252, 1913000180, 20884521014241; 8888145252, 1913000181, 20884521014241; 8888145252, 1914000241, 20884521014241; 8888145252, 1914800206, 20884521014241; 8888145252, 1915800101, 20884521014241; 8888145252, 1917200226, 20884521014241; 8888145252, 1935100108, 20884521014241; 8888145252, 1935100109, 20884521014241; 8888145252, 2002900149, 20884521014241; 8888145252, 2009300077, 20884521014241; 8888145252, 2014900160, 20884521014241; 8888145252, 2015400078, 20884521014241; 8888145252, 2019500174, 20884521014241; 8888145252, 2019500178, 20884521014241; 8888145252, 2019500270, 20884521014241; 8888145252, 2020400103, 20884521014241; 8888145252, 2020400104, 20884521014241; 8888145252, 2023300107, 20884521014241; 8888145252, 2027200208, 20884521014241; 8888145252, 2028000088, 20884521014241; 8888145252, 2030300103, 20884521014241; 8888145252, 2034400154, 20884521014241; 8888145252, 2034400173, 20884521014241; 8888145252, 2104100103, 20884521014241; 8888145252, 2104600208, 20884521014241; 8888145252, 2104600211, 20884521014241; 8888145252, 2104800077, 20884521014241; 8888145252, 2106900104, 20884521014241; 8888145252, 2124600211, 20884521014241; 8888145253, 1715800114, 10884521014275; 8888145253, 1716500174, 10884521014275; 8888145253, 1717200148, 10884521014275; 8888145253, 1717900197, 10884521014275; 8888145253, 1718600099, 10884521014275; 8888145253, 1719300095, 10884521014275; 8888145253, 1720000122, 10884521014275; 8888145253, 1721300154, 10884521014275; 8888145253, 1817700211, 10884521014275; 8888145253, 1828900082, 10884521014275; 8888145253, 1829500105, 10884521014275; 8888145253, 1829500127, 10884521014275; 8888145253, 1832300107, 10884521014275; 8888145253, 1833100105, 10884521014275; 8888145253, 1833800129, 10884521014275; 8888145253, 1917600122, 10884521014275; 8888145253, 1926100269, 10884521014275; 8888145253, 2026000061, 10884521014275; 8888145253, 2027200253, 10884521014275; 8888145253, 2102500101, 10884521014275; 8888145253, 2104100104, 10884521014275; 8888145253, 2124600200, 10884521014275; 8888145253, 1715800114, 20884521014272; 8888145253, 1716500174, 20884521014272; 8888145253, 1717200148, 20884521014272; 8888145253, 1717900197, 20884521014272; 8888145253, 1718600099, 20884521014272; 8888145253, 1719300095, 20884521014272; 8888145253, 1720000122, 20884521014272; 8888145253, 1721300154, 20884521014272; 8888145253, 1817700211, 20884521014272; 8888145253, 1829500127, 20884521014272; 8888145253, 1832300107, 20884521014272; 8888145253, 1833100105, 20884521014272; 8888145253, 1917600122, 20884521014272; 8888145253, 1926100269, 20884521014272; 8888145253, 2027200253, 20884521014272; 8888145253, 2102500101, 20884521014272; 8888145253, 2124600200, 20884521014272; 8888145254, 1715800115, 10884521014329; 8888145254, 1716500175, 10884521014329; 8888145254, 1717800131, 10884521014329; 8888145254, 1717900146, 10884521014329; 8888145254, 1718600100, 10884521014329; 8888145254, 1719300096, 10884521014329; 8888145254, 1720500101, 10884521014329; 8888145254, 1833100104, 10884521014329; 8888145254, 1835300224, 10884521014329; 8888145254, 1903500127, 10884521014329; 8888145254, 1917200227, 10884521014329; 8888145254, 2027200201, 10884521014329; 8888145254, 1715800115, 20884521014326; 8888145254, 1716500175, 20884521014326; 8888145254, 1717800131, 20884521014326; 8888145254, 1717900146, 20884521014326; 8888145254, 1718600100, 20884521014326; 8888145254, 1719300096, 20884521014326; 8888145254, 1720500101, 20884521014326; 8888145254, 1720700110, 20884521014326; 8888145254, 1833100104, 20884521014326; 8888145254, 1835300224, 20884521014326; 8888145254, 1903500127, 20884521014326
Devices named in this recall
20 devices in the FDA device registry whose identifier appears in the recall's code information.
- MAHURKAR 8888145001Mozarc Medical US LLC · Catheter, hemodialysis, implanted1 recall45 reports
- MAHURKAR 8888145251Mozarc Medical US LLC · Catheter, hemodialysis, implanted1 recall1 death33 reports
- MAHURKAR 8888145002Mozarc Medical US LLC · Catheter, hemodialysis, implanted1 recall12 reports
- MAHURKAR 8888123435Mozarc Medical US LLC · Catheter, hemodialysis, implanted1 recall10 reports
- MAHURKAR 8888145252Mozarc Medical US LLC · Catheter, hemodialysis, implanted1 recall9 reports
- MAHURKAR 8888145003Mozarc Medical US LLC · Catheter, hemodialysis, implanted1 recall2 reports
- MAHURKAR 8888123402Mozarc Medical US LLC · Catheter, hemodialysis, implanted1 recall1 report
- MAHURKAR 8888145254Mozarc Medical US LLC · Catheter, hemodialysis, implanted1 recall1 report
- MAHURKAR 8888119385Mozarc Medical US LLC · Catheter, hemodialysis, implanted1 recall0 reports
- MAHURKAR 8888128485Mozarc Medical US LLC · Catheter, hemodialysis, implanted1 recall0 reports
- MAHURKAR 8888133535Mozarc Medical US LLC · Catheter, hemodialysis, implanted1 recall0 reports
- MAHURKAR 8888145004Mozarc Medical US LLC · Catheter, hemodialysis, implanted1 recall0 reports
- MAHURKAR 8888145253Mozarc Medical US LLC · Catheter, hemodialysis, implanted1 recall0 reports
- MAHURKAR 8888119362Mozarc Medical US LLC · Catheter, hemodialysis, implanted1 recall0 reports
- MAHURKAR 8888128452Mozarc Medical US LLC · Catheter, hemodialysis, implanted1 recall0 reports
- MAHURKAR 8888133502Mozarc Medical US LLC · Catheter, hemodialysis, implanted1 recall0 reports
- MAHURKAR 8888145027Mozarc Medical US LLC · Catheter, hemodialysis, implanted1 recall0 reports
- MAHURKAR 8888145028Mozarc Medical US LLC · Catheter, hemodialysis, implanted1 recall0 reports
- MAHURKAR 8888145029Mozarc Medical US LLC · Catheter, hemodialysis, implanted1 recall0 reports
- MAHURKAR 8888145030Mozarc Medical US LLC · Catheter, hemodialysis, implanted1 recall0 reports
Product lines
Other devices under the same FDA submission
23 devices cleared under K111372 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Palindrome 8888145014Mozarc Medical US LLC · Catheter, hemodialysis, implanted1 recall312 reports
- Palindrome 8888145015Mozarc Medical US LLC · Catheter, hemodialysis, implanted2 recalls1 death219 reports
- Palindrome 8888145016Mozarc Medical US LLC · Catheter, hemodialysis, implanted1 recall1 death38 reports
- Palindrome 8888145017Mozarc Medical US LLC · Catheter, hemodialysis, implanted1 recall22 reports
- Palindrome 8888145058Mozarc Medical US LLC · Catheter, hemodialysis, implanted1 recall15 reports
- Palindrome 8888145018Mozarc Medical US LLC · Catheter, hemodialysis, implanted1 recall12 reports
- Palindrome 8888145040Mozarc Medical US LLC · Catheter, hemodialysis, implanted1 recall1 death12 reports
- Palindrome 8888145039Mozarc Medical US LLC · Catheter, hemodialysis, implanted1 recall6 reports
- Palindrome 8888145041Mozarc Medical US LLC · Catheter, hemodialysis, implanted1 recall3 reports
- Palindrome 8888145059Mozarc Medical US LLC · Catheter, hemodialysis, implanted1 recall2 reports
- Palindrome 8888119360Mozarc Medical US LLC · Catheter, hemodialysis, implanted1 recall1 report
- Palindrome 8888145060Mozarc Medical US LLC · Catheter, hemodialysis, implanted1 recall1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 90311).
- Z-1312-2022 · Open, ClassifiedPalindrome Precision Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
- Z-1313-2022 · Open, ClassifiedPalindrome Precision H Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
- Z-1314-2022 · Open, ClassifiedPalindrome Precision SI Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
- Z-1315-2022 · Open, ClassifiedPalindrome Precision HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
- Z-1316-2022 · Open, ClassifiedPalindrome Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
- Z-1317-2022 · Open, ClassifiedPalindrome H Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
- Z-1318-2022 · Open, ClassifiedPalindrome SI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
- Z-1319-2022 · Open, ClassifiedPalindrome HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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