Device product
CAPIO, Monodeck, Violet Monofilament Polydioxanone Suture, 1 x 48 inches (122cm) Absorbable Surgical Suture, Rx Only, Teleflex Medical. Product Code: 833-137.
Z-1534-2014
Product summary
- Firm
- Teleflex Medical
- Event
- Event 67973
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7,380 ea (total)
- Official record key
device-enforcement:Z-1534-2014
Official wording
Reason: The product did not meet minimum and/or average minimum Teleflex resorption strength requirements.
Code information: Product Code: 833-137, Lot numbers: 02A0901938, 02B0901537, 02H1001025, 02H1001026, 02H1001027, 02C1102979, 02C1102983, 02D1300294, 02D1301164, 02C1302078, 02D1302468.
Distribution pattern: 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.
Derived failure modes
-
Unknown
The product did not meet minimum and/or average minimum Teleflex resorption strength requirements.