Teleflex Medical, Research Triangle Park, NC, Polypropylene, Rx Only, Sterile, Distributed by Boston Scientific, Natick,
FDA device recall Z-1557-2014 · posted 2014-05-07 · Terminated
Recall details
- Recalling firm
- Teleflex Medical
- Reason for recall
- Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.
- Action taken
- Urgent Medical Device Recall Notification letters were issued on March 11, 2014 to consignees. The letter requested that customers discontinue use and quarantine any product on hand. The attached Recall Acknowledgment Form should be completed and returned to Teleflex regardless of whether affected product is on hand or not. Once received a customer service representative will contact customers with instructions on how to return the affected product. Questions should be directed to Customer Service at 1-866-246-6990.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- GAQ
- Quantity affected
- 32,271 ea.
- Distribution
- Worldwide Distribution -- USA, including the states of AL, CA, FL, GA, IL, IN, KS, LA, ME, MA, MI, MN, MS, MO, NV, NJ, NM, NY, OH, PA, RI, SC, TN, TX, UT, VA, WV, and WI; and countries of Canada, Germ
- Date initiated
- 2014-03-11
- Date posted
- 2014-05-07
- Date terminated
- 2017-08-14
- 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 |
|---|---|---|
| SURGICAL SUTURES, PGL, GUT, DEKLENE, OPTHAMEND ETC (K930738) | Deknatel, Inc. | 1994-07-26 |