Recall Z-2154-2014
Teleflex Medical · initiated July 10, 2014
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
RUSCH Foley Urinary Catheter Insertion Tray with 10cc syringe, BZK Swabs, Sterile, Rx only, Teleflex Medical Product Code: 76730.
Codes / lots: Product Code: 76730, Lot number: 307505.
Reason for recall
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.
FDA-determined cause: Process control
Action taken
Consignees were notified via letter on/about 07/10/2014.
Details
- Recall number
- Z-2154-2014
- Initiated
- July 10, 2014
- Posted by FDA
- August 6, 2014
- Terminated
- November 25, 2015
- Product code
- FCM – Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
- Quantity
- 720
- Distribution
- Nationwide distribution in CA, CT, FL, MA, MO, NJ, OH, OR and TX.
- Recalling firm
- Teleflex Medical, Durham, NC