RUSCH Foley Urinary Catheter Insertion Tray with 10cc syringe, BZK Swabs, Sterile, Rx only, Teleflex Medical Product Cod
FDA device recall Z-2154-2014 · posted 2014-08-06 · Terminated
Recall details
- Recalling firm
- Teleflex Medical
- 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.
- Action taken
- Consignees were notified via letter on/about 07/10/2014.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FCM
- Quantity affected
- 720
- Distribution
- Nationwide distribution in CA, CT, FL, MA, MO, NJ, OH, OR and TX.
- Date initiated
- 2014-07-10
- Date posted
- 2014-08-06
- Date terminated
- 2015-11-25
- Location
- Durham, NC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FOLEY CATHETER INSERTION TRAY (10CC) (K901185) | Orion Life Systems, Inc. | 1990-07-20 |