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Catalog A897514, SureStep" Foley Tray, Silicone, Drainage… recallZ-2533-2021 · C.R. Bard Inc · initiated Aug 5, 2021

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 C.R. Bard 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

There is potential for packaging defects that may impact the sterile barrier.

FDA root cause category: Packaging change control

What the company is doing

Customer letters were sent "URGENT MEDICAL DEVICE RECALL" via FedEx and email to affected consignees on August 13, 2021. Customers are asked to please Take the Following Actions: 1. Note that there may be a supply disruption in Foley catheter trays from all sources due to the current product shortage driven by this issue and other issues with third party Foley manufacturers. 2. Please check all inventory locations within your institution for the specific catalog and lot number combinations listed in Attachment 1 of this recall notice. 3. Share this recall notice with any users of the product, within your facilities, to ensure they are also aware of this recall notice. 4. If you purchased this product from a distributor, contact your distributor for further instructions. 5. Complete and return the attached Customer Response Form to the BD contact noted on the form confirming acknowledgement of the notification, whether or not you have any affected product, so that BD may acknowledge your receipt of this notification and process any applicable order credit. 6. Report any adverse health consequences experienced with the use of this product to BD at the contact information below. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program BD will process order credits, including shipping costs, for all customers discontinuing use of and returning product as a result of this notification, following receipt of the completed Customer Response Form. BD has implemented actions to prevent recurrence of this product issue. The firm, BD, sent an updated letter dated October 8, 2021 informing customers of additional affected lot numbers that were distributed between March 2021 through July 23, 2021.

Recall details

Recall number
Z-2533-2021
Status
Open, Classified
Initiated by the company
Aug 5, 2021
Posted by the FDA
Sep 23, 2021
Recalling firm
C.R. Bard Inc
Quantity
1710 units
Product code
GBM
FDA submissions
K760093
Distribution
US Nationwide distribution.

Product description

Catalog A897514, SureStep" Foley Tray, Silicone, Drainage Bag, StatLock" Stabilization Device

Code information (models, lots, serial numbers)

Catalog A897514, Lot NGFR2808, UDI (01)00801741104510(17)201228(10)

Devices named in this recall

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

Other products in the same recall event

The FDA groups related products into one recall event (event 88499).

Sources and updates

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