CP Medical Inc recalls Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI: (01)10790986000657 (17)220430…
- Recall date
- October 18, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0655-2020
- FDA classification
- Class II
- Brand / firm
- CP Medical Inc
- Sold / distributed
- USA - product distributed in CA, OH, WA, PA, KY, UT, FL, TN, SC, IA, NE
Why it was recalled
Failed to meet USP minimum average value for knot pull (tensile) strength.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI: (01)10790986000657 (17)220430 (10)17050970
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