Recall Z-2327-2012 ยท EZC Catheter, Coude
C.R. Bard, Inc., Urological Division
Bard Foley procedural trays packaged in breather bags. The product is packaged ten units in each shipper box, and are sold sterile for single use. Used to catheterize patients. The finished trays are sold in Tyvek breather bags.
| Date | Sep 7, 2012 (initiated Jun 29, 2012) |
| Status | Terminated |
| Reason | Incomplete seal on sterile packages of product. |
| Root cause | Process control |
| Action | C. R. Bard Inc, sent a Urgent Product Recall Notification letter dated June 27. 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. This notification is being sent because there is a potential for a limited number of units within the subject lots (noted above) that may contain an open seal of the sterile packages. The issue is visually obvious even before the package is opened. No patient injury or adverse events have been reported. Do not use or further distribute any of the affected products. Once the product |
| Quantity | 56,694 units |
| Distribution | Nationwide distribution: USA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.