Recall Z-0771-2017 ยท KOD Catheter, Urological
Teleflex Medical
RUSCH, Pocket PAC IC Intermittent Cath Kit, 8 FR, 12 FR, 14 FR, 10 FR and 16 FR, Rx Only, Sterile, Intermittent self-catheterization
| Date | Nov 22, 2016 |
| Status | Terminated |
| Reason | Labeling Inconsistency: The products have been labeled with the incorrect expiration date which exceeds the actual, validated 35-month shelf life. |
| Root cause | Error in labeling |
| Action | Teleflex sent an Urgent Medical Device Recall Notification letter dated November 22, 2016, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers with affected stock, immediately discontinue use and quarantine any affected products. To return product, customers were advised to complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recall@teleflex.com. Customers with no affected stock should also complete the enclosed Recall Acknowledgment Form to confirm |
| Quantity | 102,843 units |
| Distribution | Nationwide Distribution to CA, CO, FL, GA, IL, KS, KY, MA, MO, MS, NC, NJ, NY, OH, OK, OR, PA and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010420 | RUSCH MMG/O'NEIL CATHETER Rusch, Inc., May 9, 2001 |