Recall Z-2154-2024 ยท MJC Catheter, Urological (Antimicrobial) And Accessories
C.R. Bard Inc
Bard Medical SureStep Foley Tray System, 16 Fr., Catalog #A319416AM; and Bard Medical Bardex IC Complete Care Infection Control Temperature-Sensing Foley Catheter Tray with Bard Hydrogel and Bacti-Guard Silver Alloy Coating, 350 ml Urine Meter, 16 Fr, Catalog #319416AM. Intended for use in the drainage and/or collection and/or measurement of urine.
| Date | Jun 18, 2024 (initiated May 9, 2024) |
| Status | Open, Classified |
| Reason | Some of the devices may function incorrectly resulting in no temperature display or erratic temperatures being displayed on the temperature monitoring devices. |
| Root cause | Component design/selection |
| Action | The recalling firm issued letters on and dated 5/9/2024 via FedEx and email. The letter to medical facilities explained the issue, contained a copy of the label for each product and showed where to find the catalog number and lot number, provided the clinical impact, and advised clinical users to review and follow instructions provided in the field action communication to avoid potential health consequences in the future. The letter also said that if the device is currently in use and functioning appropriately, the device does not need to be replaced. Actions to be taken by the medical faci |
| Quantity | 6,420 devices |
| Distribution | Distribution was nationwide. There was no government/military/foreign distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040658 | BARDEX I.C. LATEX FOLEY CATHETER C.R. Bard, Inc., Sep 29, 2004 |