Device product
Covidien CV-9590 Velosorb Fast Braided Fast absorbable Suture 14 Metric 36" 90 cm, GS-24 Taper 1/2 40 mm, undyed, UDI: 10884521151307
Z-0949-2021
Product summary
- Event
- Event 87036
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3060 units
- Official record key
device-enforcement:Z-0949-2021
Official wording
Reason: Due to a manufacturing error, there is a potential that sutures may exhibit inadequate tensile strength. This could potentially lead to intra-operative and post-operative complications such as suture break or wound dehiscence.
Code information: Lot # 19062715X
Distribution pattern: US: NJ OUS: Germany, Croatia, Italy, India, Poland and Spain.
Derived failure modes
-
Manufacturing or process control
manufacturing error