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Port Access Needle recallZ-2670-2020 · Becton Dickinson & Company · initiated Jun 19, 2020

Terminated

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 Becton Dickinson & Company 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

Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A crack or break could result in potential blood loss, catheter occlusion, air embolism, under or interrupted infusion, or site contamination which could lead to infection.

FDA root cause category: Process control

What the company is doing

URGENT MEDICAL DEVICE RECALL notification letters dated 6/19/20 were sent to customers. PLEASE TAKE THE FOLLOWING ACTIONS: 1. Immediately review your inventory for the specific catalog and lot numbers referenced in Attachment A. Discontinue use of those devices and destroy all product subject to this recall following your institutions process for destruction. MDS-20-1979 Page 2 of 28 BD Medical 1 Becton Drive Franklin Lakes, NJ 07417 USA bd.com 2. Share this notification with all users of the product within your facility network to ensure they are also aware of this recall. 3. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification per FDA requirements and subsequently process your credit accordingly for the discarded material. a. Customers who purchased product directly from BD will receive credit. b. Customers who did not purchase product directly from BD will need to contact their distributor to obtain credit. 4. Report any adverse health consequences experienced with the use of this product to BD at [email protected]. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program via: Web: MedWatch website at www.fda.gov/medwatch Phone: 1800FDA1088 (18003321088) Mail: MedWatch, HF2, FDA, 5600 Fishers Lane, Rockville, MD 208529787 Customer/Technical Support Phone: 8002901689 Monday Friday between 8:00 am to 5:00 pm MDT [email protected] An Urgent Medical Device Recall notification letter dated 8/25/20 was sent to customers informing them of two additional lots of affected product. An URGENT MEDICAL DEVICE RECALL UPDATE dated 10/7/20 was sent to customers informing them of two additional lots of affected product.

Recall details

Recall number
Z-2670-2020
Status
Terminated
Initiated by the company
Jun 19, 2020
Posted by the FDA
Jul 20, 2020
Recalling firm
Becton Dickinson & Company
Quantity
5,296,132 total
Product code
PTI
FDA submissions
K153440
Distribution
Worldwide Distribution

Product description

PowerLoc MAX Power Injectable Infusion Set; Catalog Numbers 0131910 (UDI 00801741047329), 0131915 (UDI 00801741047336), 0131975 (UDI 00801741047343), 0132010 (UDI 00801741047350), 0132015 (UDI 00801741047367), 0132075 (UDI 00801741047374), 0132210 (UDI 00801741047381), 0132215 (UDI 00801741047398), 0132275 (UDI 00801741047404), 0141910 (UDI 00801741047411), 0141915 (UDI 00801741047428), 0141975 (UDI 00801741047435), 0142010 (UDI 00801741047442), 0142015 (UDI 00801741047459), 0142075 (UDI 00801741047466), 0142210 (UDI 00801741047473), 0142215 (UDI 00801741047480), 0142275 (UDI 00801741047497)

Code information (models, lots, serial numbers)

Show the full code information (2k characters)

Catalog Numbers 0131910 (UDI 00801741047329), 0131915 (UDI 00801741047336),  0131975 (UDI 00801741047343), 0132010 (UDI 00801741047350), 0132015 (UDI 00801741047367), 0132075 (UDI 00801741047374), 0132210 (UDI 00801741047381), 0132215 (UDI 00801741047398), 0132275 (UDI 00801741047404), 0141910 (UDI 00801741047411), 0141915 (UDI 00801741047428), 0141975 (UDI 00801741047435), 0142010 (UDI 00801741047442), 0142015 (UDI 00801741047459), 0142075 (UDI 00801741047466), 0142210 (UDI 00801741047473), 0142215 (UDI 00801741047480), 0142275 (UDI 00801741047497).  Lot Numbers: ASCXF007 ASCXF019 ASDRF074 ASDRF075 ASDRF079 ASDRF084 ASDVF021 ASCXF001 ASDNF040 ASDNF043 ASDVF031 ASDWF118 ASCXF006 ASCXF018 ASDRF053 ASDRF058 ASDRF060 ASDRF071 ASDVF029 ASDWF117 ASCYF028 ASCYF029 ASCZF025 ASDPF029 ASDQF015 ASDQF039 ASDQF041 ASDRF065 ASDTF043 ASDTF054 ASDTF055 ASDTF061 ASDVF018 ASCYF023 ASCYF024 ASDTF031 ASDTF032 ASDTF033 ASDTF037 ASDTF038 ASCYF040 ASCYF076 ASCZF055 ASDNF001 ASDNF002 ASDNF004 ASDNF018 ASDQF036 ASDTF075 ASDTF096 ASDTF104 ASDTF105 ASDTF115 ASDUF006 ASDUF019 ASDUF026 ASDUF033 ASDUF042 ASDUF059 ASDUF063 ASDUF078 ASDUF097 ASDUF102 ASDUF105 ASDUF111 ASDUF119 ASDVF005 ASDVF014 ASDWF070 ASDWF081 ASDWF086 ASDWF102 ASDWF114 ASDTF023 ASDTF024 ASDTF025 ASDTF034 ASDTF035 ASCYF020 ASDTF027 ASDTF028 ASDTF036 ASCYF021 ASCYF022 ASDTF016 ASDTF017 ASDTF018 ASDTF019 ASDWF106 ASCXF009 ASCXF010 ASDRF088 ASDRF089 ASDRF092 ASDRF095 ASDRF096 ASDXF071 ASDXF073 ASENF043 ASENF047 ASENF048 ASCXF002 ASDNF042 ASDXF083 ASDXF084 ASCXF005 ASCXF008 ASDSF028 ASDSF032 ASDSF044 ASDSF051 ASDSF055 ASDSF056 ASENF061 ASENF075 ASEQF074 ASEQF086 ASEQF099 ASDNF027 ASDNF031 ASDNF035 ASDNF038 ASDQF021 ASDQF025 ASDQF030 ASDVF088 ASDWF003 ASDWF009 ASDWF012 ASDWF019 ASDWF072 ASERF011 ASDQF002 ASDQF003 ASDQF004 ASDQF006 ASDTF101 ASDVF084 ASDXF036 ASDXF037 ASCZF056 ASCZF062 ASDNF003 ASDNF005 ASDNF029 ASDNF032 ASDNF037 ASDNF046 ASDNF052 ASDTF040 ASDTF044 ASDTF059 ASDTF076 ASDTF098 ASDTF106 ASDUF003 ASDUF009 ASDUF021 ASDUF028 ASDUF043 ASDUF060 ASDUF077 ASDUF095 ASDUF108 ASDUF112 ASDWF073 ASDWF082 ASDWF091 ASDWF092 ASDWF113 ASDWF120 ASDXF002 ASDXF015 ASDZF021 ASDZF029 ASDZF037 ASDZF047 ASENF007 ASENF069 ASENF079 ASENF083 ASEPF007 ASCYF018 ASCYF019 ASCZF026 ASDRF047 ASDRF048 ASDRF049 ASDRF050 ASDXF049 ASDXF050 ASENF026 ASENF027 ASENF028 ASERF006 ASERF007 ASCYF007 ASDRF063 ASCYF005 ASCYF006 ASDRF009 ASDRF015 ASDRF016 ASDRF028 ASDVF068 ASDZF060 ASDZF063 ASDZF066 ASDZF068 ASERF026 ASERF028

Devices named in this recall

18 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 85853).

Sources and updates

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