Polypropylene Surgical Sutures, brand Webglo, for vet use. Product is sterile. Part number: GP8665 Product Usage: For use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological surgery.
This recall has been terminated (originally issued August 5, 2016).
- Company
- Riverpoint Medical, Llc
- Recall Initiated
- August 5, 2016
- Terminated
- December 22, 2016
- Recall Number
- Z-2762-2016
- Quantity
- 61 boxes distributed in the US only
- Firm Location
- Portland, OR
- Official Source
- View on FDA website ↗
Reason for Recall
Polypropylene Surgical Sutures are recalled because the seals may become open during distribution or subsequent packaging.
Distribution
US Nationwide distribution in the states of ID, MA, OR, NY and in the country of Australia.
Lot / Code Info
Lot For Vet use: 160218-05V
Root Cause
Nonconforming Material/Component
Action Taken
Riverpoint Medical sent an Urgent Medical Device letter, dated August 5. 2016, and the Customer Response Form to their customers via email. The letter identified the affected product, problem and actions to be taken. Customers are instructed to check inventory, discontinue selling affected sutures and return affected devices to the firm. Distributors are instructed to notify their downstream customers. Consignees should submit the Customer Response Forms. For questions call Riverpoint Medical at 1-866-445-4929.