Recall Z-2154-2014 ยท FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
Teleflex Medical
RUSCH Foley Urinary Catheter Insertion Tray with 10cc syringe, BZK Swabs, Sterile, Rx only, Teleflex Medical Product Code: 76730.
| Date | Aug 6, 2014 (initiated Jul 10, 2014) |
| Status | Terminated |
| Reason | Labeling error: The manufacturing date is the same as the expiration date. The manufacturing date is correct, however the expiration date incorrectly indicates that the product is expired. |
| Root cause | Process control |
| Action | Consignees were notified via letter on/about 07/10/2014. |
| Quantity | 720 |
| Distribution | Nationwide distribution in CA, CT, FL, MA, MO, NJ, OH, OR and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K901185 | FOLEY CATHETER INSERTION TRAY (10CC) Orion Life Systems, Inc., Jul 20, 1990 |