Recall Z-0771-2017
Teleflex Medical · initiated November 22, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
RUSCH, Pocket PAC IC Intermittent Cath Kit, 8 FR, 12 FR, 14 FR, 10 FR and 16 FR, Rx Only, Sterile, Intermittent self-catheterization
Codes / lots: Product Code: 10096080, Lot number: 74F1501853 (8 FR); Product Code: 10096120, Lot numbers: 74E1602795, 74F1503201, 74G1600723 & 74J1500576 (12 FR); Product Code: 10096140, Lot numbers: 74A1600023, 74A1601105, 74A1602234, 74D1602007, 74E1602235, 74E1602796, 74F1501855, 74G1600486, 74H1500530 & 74L1500363 (14 FR); Product Code: 10096100, Lot numbers: 74A1600799, 74A1600800, 74A1602236, 74A1603122, 74D1600231, 74D1600923, 74D1601540, 74D1602136, 74E1600845, 74E1601768, 74E1602237, 74F1501857, 74F1501962, 74F1601966, 74F1601988, 74H1500534, 74H1500978, 74J1501157, 74K1502306, 74L1500364, 74L1501303, 74L1501938, 74M1500227 and 74M1501087 (10 FR) and Product Code: 10096160, Lot numbers: 74A1600024, 4A1600801, 74A1601106, 74A1603123, 74D1601541, 74E1600846, 74E1602797, 74G1600724, 74H1500979, 74J1501158, 74K1501837, 74L1501202 &74L1501939 (16 FR).
Reason for recall
Labeling Inconsistency: The products have been labeled with the incorrect expiration date which exceeds the actual, validated 35-month shelf life.
FDA-determined cause: Error in labeling
Action taken
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 receipt of the letter. Customers with questions should contact Customer Service at 1-866-246-6990.
Details
- Recall number
- Z-0771-2017
- Initiated
- November 22, 2016
- Terminated
- November 24, 2017
- Product code
- KOD – Catheter, Urological
- 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.
- Recalling firm
- Teleflex Medical, Research Triangle Park, NC