Recalls / —

—#188832

Product

Catalog A800360, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray

FDA product code

EZC — Catheter, Coude

Device class

Class 2

Medical specialty

Gastroenterology, Urology

510(k) numbers

K910846

Affected lot / code info

Catalog A800360, Lot NGFR3570, UDI (01)00801741073922(17)251228(10)

Why it was recalled

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

Root cause (FDA determination)

Packaging change control

Action the firm took

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.

Recalling firm

Firm

C.R. Bard Inc

Address

8195 Industrial Blvd NE, Covington, Georgia 30014-1497

Distribution

Distribution pattern

US Nationwide distribution.

Timeline

Recall initiated

2021-08-05

Posted by FDA

2021-09-23

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #188832. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.