Z-0949-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 10, 2021
- Initiation Date
- December 9, 2020
- Termination Date
- April 21, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3060 units
Product Description
Covidien CV-9590 Velosorb Fast Braided Fast absorbable Suture 14 Metric 36" 90 cm, GS-24 Taper 1/2 40 mm, undyed, UDI: 10884521151307
Reason for Recall
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.
Distribution Pattern
US: NJ OUS: Germany, Croatia, Italy, India, Poland and Spain.
Code Information
Lot # 19062715X