FDA-Device2019-12-18Class II
Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI: (01)10790986000657 (17)220430 (10)17050970
CP Medical Inc
Hazard
Failed to meet USP minimum average value for knot pull (tensile) strength.
Sold states
USA - product distributed in CA, OH, WA, PA, KY, UT, FL, TN, SC, IA, NE
Affected count
174 boxes 12 per box (plus 36 samples) - total of 2124 sutures
Manufactured in
1775 Corporate Dr Ste 150, N/A, Norcross, GA, United States
Products
Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI: (01)10790986000657 (17)220430 (10)17050970
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0655-2020Don't want to check this manually?
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