Nonabsorbable Polypropylene Synthetic Suture-Deklene, DEK BL MF 0 TC-43 2N 48, Catalog #833-123
FDA device recall Z-1018-2007 · posted 2007-07-17 · Terminated
Recall details
- Recalling firm
- Teleflex Creek Dr
- Reason for recall
- Suture Diameter/Strength specification failure: The products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage.
- Action taken
- Consignees were notified by letter on/about 06/07/2007. They were advised to cease use, remove and quarantine all affected product immediately. Affected products are to be returned to Teleflex Medical. An Acknowledgement & Stock form was included to be completed and returned via fax to Teleflex Medical.
- Root cause
- Other
- Status
- Terminated
- Product code
- GAM
- Quantity affected
- 1920 units total for all types of sutures
- Distribution
- Worldwide-, USA including states of CO, FL, IL, IN, MA, and OH, and Countries of Canada, France and Germany
- Date initiated
- 2007-06-06
- Date posted
- 2007-07-17
- Date terminated
- 2008-03-14
- 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 |
| SUTURES POLYPROP., POLYETHELINE, NYLON & SILK (K930739) | Deknatel, Inc. | 1994-07-26 |