FDAFDA · Food and drugs·Recall number Z-0347-2014
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
Published November 27, 2013 · Recall initiated: December 13, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Riverpoint Medical is recalling PGLA Surgical Suture (Vilet) because the label indicates the suture is undyed and it is actually a violet colored suture.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Riverpoint Medical, LLC
- Distributor
- US Distribution in the states of: AZ, FL, and TX.
- Lot
- Lot 120716-01
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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