Polyglycolic-Lactic Acid Absorbable Surgical Suture Label reads in part "Coated VILET *** (Pol...
FDA Recall #Z-0347-2014 — Class II — December 13, 2012
Product Description
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
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.
Recalling Firm
Riverpoint Medical, LLC — Portland, OR
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
1932 pieces
Distribution
US Distribution in the states of: AZ, FL, and TX.
Code Information
Lot 120716-01
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated