CAPIO, Monodeck, Violet Monofilament Polydioxanone Suture, 1 x 48 inches (122cm) Absorbable Surgical Suture, Rx Only, Te
FDA device recall Z-1534-2014 · posted 2014-05-01 · Terminated
Recall details
- Recalling firm
- Teleflex Medical
- Reason for recall
- The product did not meet minimum and/or average minimum Teleflex resorption strength requirements.
- Action taken
- Teleflex Medical sent an Urgent Medical Device Recall Notification dated March 11, 2014. The letter identified the affected product, problem and actions to be taken. Custmers were instructed to return all affected product to Teleflex Medical per the instructions on the Urgent Recall Notice. Customers were asked to complete the enclosed Recall Acknowledgement Form and fax to 1-866-804-9881, Attn: Customer Service. For questions contact your local sales representative or Customer Service at 1-866-246-6990
- Root cause
- Other
- Status
- Terminated
- Product code
- NEW
- Quantity affected
- 7,380 ea (total)
- Distribution
- Worldwide Distribution - US Nationwide in the states of CA, CO, GA, LA, IL, MA, MI, MN, MO, NC, and in the countries of Ireland and Singapore.
- Date initiated
- 2014-03-11
- Date posted
- 2014-05-01
- Date terminated
- 2016-03-29
- Location
- Research Triangle Park, NC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MONODEK SYNTHETIC ABSORBABLE SURGICAL SUTURE (K030212) | Genzyme Biosurgery | 2003-03-27 |