CP Medical Inc recalls Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI: (01)10790986000657 (17)220430

Recalled December 18, 2019 · FDA recall Z-0655-2020 · CP Medical

Hazard

Failed to meet USP minimum average value for knot pull (tensile) strength. · FDA Class II

Units

174 boxes 12 per box (plus 36 samples) - total of 2124 sutures

Sold at

USA - product distributed in CA, OH, WA, PA, KY, UT, FL, TN, SC, IA, NE

Description

Failed to meet USP minimum average value for knot pull (tensile) strength.

Product

Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI: (01)10790986000657 (17)220430 (10)17050970

Manufacturer(s)

CP Medical Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →