Recall Z-1534-2014
Teleflex Medical · initiated March 11, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
CAPIO, Monodeck, Violet Monofilament Polydioxanone Suture, 1 x 48 inches (122cm) Absorbable Surgical Suture, Rx Only, Teleflex Medical. Product Code: 833-137.
Codes / lots: Product Code: 833-137, Lot numbers: 02A0901938, 02B0901537, 02H1001025, 02H1001026, 02H1001027, 02C1102979, 02C1102983, 02D1300294, 02D1301164, 02C1302078, 02D1302468.
Reason for recall
The product did not meet minimum and/or average minimum Teleflex resorption strength requirements.
FDA-determined cause: Other
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
Details
- Recall number
- Z-1534-2014
- Initiated
- March 11, 2014
- Posted by FDA
- May 1, 2014
- Terminated
- March 29, 2016
- Product code
- NEW – Suture, Surgical, Absorbable, Polydioxanone
- Quantity
- 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.
- Recalling firm
- Teleflex Medical, Research Triangle Park, NC
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1535-2014 Class II | Dekna-lok, 1 x 17.78 cm, Violet Braided Polyglycolic Acid Coated Suture, Synthetic…The product did not meet minimum and/or average minimum Teleflex resorption strength requirements. | 03/11/2014Terminated |