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Monarch recallZ-0070-2025 · Merit Medical Systems, Inc. · initiated Aug 19, 2024

Open, Classified

Is my device affected?

  1. 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.
  2. If yours is listed, follow the instructions from Merit Medical Systems, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. 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

Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.

FDA root cause category: Packaging process control

What the company is doing

On 8/19/24, recall notices were emailed to customers asking them to do the following: 1) If affected devices are discovered, quarantine them, discontinue use and distribution, and return to the recalling firm. 2) Ensure that applicable personnel within your organization are made aware of this field action. 3) If the product has been further distributed to other facilities, institutions, or manufacturers, please ensure this notice is immediately shared with them and note the quantity distributed on the customer response form. 4) Complete and return the customer response form via email to [email protected] If you have any questions concerning this communication, please contact the firm's Sales Representatives or Customer Service via email at [email protected] or via phone at +1 800 356 3748, Hours: 6 am to 6 pm MST, Mon-Fri.

Recall details

Recall number
Z-0070-2025
Status
Open, Classified
Initiated by the company
Aug 19, 2024
Posted by the FDA
Oct 11, 2024
Recalling firm
Merit Medical Systems, Inc.
Quantity
7,099
Product code
OEQ
Distribution
Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, DC, 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, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of France, Italy, Jamaica, Ireland, Paraguay, Australia, India, Nepal, Japan.

Product description

Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K05-00296L, K05-00399D, K05-00404C, K05-00410G, K05-00438G, K05-00502F, K05-00564L, K05-00587D, K05-00612Q, K05-00704F, K05-00724F, K05-00793B, K05-00798, K05-00890D, K05-00890D, K05-00944D, K05-00956D, K05-01018C, K05-01051, K05-01104G, K05-01140D, K05-01194G, K05-01274D, K05-01304A, K05-01756B, K05-01820B, K05-01853A, K05-01855L, K05-01895A, K05-01933A, K05-02161, K05-02431A, K05-02487A, K05-02489C, K05-02495B, K05-02554, K05-02573, K05-02575, K05-02595, K05-02595, K05-02657A, K05-02810, K05-02887, K05-03069A, K05-03095B, K05-03112, K05-03124, K05-03150, K05-50037G

Code information (models, lots, serial numbers)

Show the full code information (4k characters)

REF/UDI-DI/Lot(Expiration): K05-00052M/00884450138120/H2934735(5/5/2027), H2943603(5/19/2027). K05-00053H/00884450052921/H2918538(4/22/2027), H2934736(5/5/2027). K05-00109G/00884450464533/H2918443(4/15/2027), H2925236(4/22/2027), H2943604(5/19/2027). K05-00137K/00884450290316/H2925237(12/31/2026), H2934737(5/12/2027). K05-00296L/00884450467824/H2918499(4/29/2027), H2925271(4/29/2027). K05-00399D/00884450138298/H2929510(4/29/2027), H2934739(5/12/2027). K05-00404C/00884450138304/H2918500(4/29/2027). K05-00410G/00884450142295/H2918501(4/15/2027), H2934833(5/12/2027). K05-00438G/00884450142301/H2918502(4/15/2027), H2934834(5/5/2027), H2978145(6/3/2027). K05-00502F/00884450138427/H2918505(4/15/2027), H2934837(5/5/2027). K05-00564L/00884450257166/H2934839(5/5/2027). K05-00587D/00884450052952/H2918446(4/22/2027), H2934744(5/5/2027), H2938620(5/12/2027). K05-00612Q/00884450138519/H2925240(4/22/2027), H2934746(5/5/2027), H2943608(5/26/2027). K05-00704F/00884450138588/H2918508(4/15/2027), H2938622(5/12/2027). K05-00724F/00884450146538/H2918509(4/15/2027). K05-00793B/00884450236987/H2918448(4/15/2027), H2929514(4/29/2027), H2938623(5/12/2027). K05-00798/00884450046951/H2925242(4/22/2027), H2943609(5/19/2027). K05-00890D/00884450453629/H2918449(4/15/2027), H2929515(4/29/2027). K05-00890D/00884450453629/H2934749(5/5/2027), H2943610(5/19/2027). K05-00944D/00884450151631/H2918450(4/15/2027), H2929516(4/29/2027). K05-00956D/00884450142448/H2918511(4/15/2027), H2925278(4/22/2027), H2938625(5/12/2027). K05-01018C/00884450152324/H2925244(4/22/2027), H2938626(5/12/2027). K05-01051/00884450047057/H2925280(4/22/2027). K05-01104G/00884450145401/H2925285(4/22/2027), H2929540(4/29/2027), H2934846(5/5/2027). K05-01140D/00884450147931/H2925286(4/22/2027), H2934847(5/5/2027), H2972616(5/26/2027). K05-01194G/00884450409091/H2925288(4/22/2027). K05-01274D/00884450160596/H2918453(4/22/2027), H2934750(5/12/2027), H2938628(5/12/2027). K05-01304A/00884450279014/H2972617(5/26/2027). K05-01756B/00884450145449/H2929520(4/29/2027). K05-01820B/00884450639115/H2929521(4/29/2027), H2943614(5/19/2027). K05-01853A/00884450153864/H2918460(4/15/2027), H2934761(5/12/2027), H2943615(5/19/2027). K05-01855L/00884450453667/H2918518(4/15/2027), H2978189(6/3/2027). K05-01895A/00884450141458/H2929522(5/26/2027). K05-01933A/00884450462768/H2918519(4/15/2027), H2934855(5/5/2027). K05-02161/00884450139738/H2918522(4/15/2027), H2925298(4/29/2027), H2943617(5/19/2027), H2978192(6/3/2027). K05-02431A/00884450150191/H2929525(4/29/2027). K05-02487A/00884450140468/H2918472(4/15/2027). K05-02489C/00884450639177/H2938638(5/12/2027). K05-02495B/00884450257326/H2925259(4/22/2027), H2934775(5/5/2027). K05-02554/00884450148372/H2934780(5/5/2027). K05-02573/00884450148884/H2918476(4/15/2027). K05-02575/00884450158500/H2938639(5/12/2027). K05-02595/00884450165881/H2918525(4/15/2027), H2929547(4/29/2027), H2938640(5/12/2027). K05-02595/00884450165881/H2972630(5/26/2027), H2982566(6/10/2027). K05-02657A/00884450639214/H2918480(4/15/2027), H2925265(4/29/2027), H2934784(5/5/2027), H2938643(5/12/2027), H2982568(6/10/2027). K05-02810/00884450253083/H2929528(4/29/2027), H2938646(5/12/2027). K05-02887/00884450285923/H2918527(4/29/2027), H2925313(4/29/2027), H2934862(5/12/2027). K05-03069A/00884450461440/H2938301(3/31/2027). K05-03095B/00884450639429/H2925319(4/22/2027), H2938649(5/12/2027). K05-03112/00884450404492/H2938650(5/12/2027). K05-03124/00884450432631/H2934820(5/5/2027), H2938651(5/12/2027), H2978212(6/3/2027). K05-03150/00884450480045/H2925320(4/22/2027). K05-50037G/0088445045609/H2925266(4/29/2027), H2934824(5/5/2027), H2938652(5/12/2027).

Devices named in this recall

49 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 95343).

Sources and updates

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