Polyglycolic-Lactic Acid Absorbable Surgical Suture Label reads in part "Coated VILET *** (Polyglacin 910) Suture UNDYED BRANDED V423 *** Riverpoint ***" PGLA surgical suture is indicated for use in general soft tissue approximation and/or ligation, including use in opthalmic procedures, but not for use in cardiovascular and neurological tissues
This recall has been terminated (originally issued November 18, 2013).
- Company
- Riverpoint Medical, Llc
- Recall Initiated
- December 13, 2012
- Posted
- November 18, 2013
- Terminated
- November 21, 2013
- Recall Number
- Z-0347-2014
- Quantity
- 1932 pieces
- Firm Location
- Portland, OR
- Official Source
- View on FDA website ↗
Reason for Recall
Riverpoint Medical is recalling PGLA Surgical Suture (Vilet) because the label indicates the suture is undyed and it is actually a violet colored suture.
Distribution
US Distribution in the states of: AZ, FL, and TX.
Lot / Code Info
Lot 120716-01
Root Cause
Employee error
Action Taken
Riverpoint sent an Urgent Medical Device Recall letter in December 2012 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were requested to review their inventory and immediately quarantine the product in question, if found. In addition, if they have further distributed the recalled product, the consignees were advised to identify their customers and notify them of this product recall. All affected product is to be returned to Riverpoint Medical. Consignees were asked to call 503-517-8001 to return recalled product and request a credit or replacement. For questions regarding this recall call 503-517-8001.