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Port Access Kit recallZ-2668-2020 · 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-2668-2020
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

SafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic Dressing Port Access Kit; Catalog Numbers PA-0031G (UDI 00801741085666), PA-0031YNG (UDI 00801741085673), PA-0032G (UDI 00801741087639), PA-0033G (UDI 00801741096433)

Code information (models, lots, serial numbers)

Catalog Numbers PA-0031G (UDI 00801741085666), PA-0031YNG (UDI 00801741085673), PA-0032G (UDI 00801741087639), PA-0033G (UDI 00801741096433).   Lot Numbers: REEN3159 REEP3067 REEQ4064 REDS3541 REDV3438 REEN2781 REEN2145 REEP3068 REDY0835 REDZ3103

Devices named in this recall

4 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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