FDA Device

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

Hazard

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

What You Should Do

Remedy

Affected customers and distributors were contacted via email on October 18, 2019 and a follow-up certified letter was sent on October 22, 2019. Those end users not contacted by CP Medical directly will be contacted by their distributor. Please contact 470-273-6049 for recall information.

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Products

Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI: (01)10790986000657 (17)220430 (10)17050970
Brand
CP Medical Inc
UPC
Product Code: 494A/494A-IMC; Lot Number: 190123-59; date of manufacture: 03/04/2019

Units Affected

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

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