FDA-Device2013-11-27Class II
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
Riverpoint Medical, LLC
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.
Sold states
US Distribution in the states of: AZ, FL, and TX.
Affected count
1932 pieces
Manufactured in
825 NE 25th Ave, Portland, OR, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0347-2014Don't want to check this manually?
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