Recall Z-2537-2021 ยท EZL Catheter, Retention Type, Balloon
C.R. Bard Inc
Catalog A943216, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabilization Device
| Date | Sep 23, 2021 (initiated Aug 5, 2021) |
| Status | Open, Classified |
| Reason | There is potential for packaging defects that may impact the sterile barrier. |
| Root cause | Packaging change control |
| Action | 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 produc |
| Quantity | 40 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040504 | BARDEX, LUBRI-SIL AND LUBRI-SIL IC ALL-SILICONE FOLEY CATHETERS C.R. Bard, Inc., May 14, 2004 |