CP Medical Inc Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI: (01)10790986000657 (17)220430 (10)17050970 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI: (01)10790986000657 (17)220430 (10)17050970
Brand
CP Medical Inc
Lot Codes / Batch Numbers
Product Code: 494A/494A-IMC, Lot Number: 190123-59, date of manufacture: 03/04/2019
Products Sold
Product Code: 494A/494A-IMC; Lot Number: 190123-59; date of manufacture: 03/04/2019
CP Medical Inc is recalling Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI: (01)107909 due to Failed to meet USP minimum average value for knot pull (tensile) strength.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Failed to meet USP minimum average value for knot pull (tensile) strength.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, FL, IN, IA, KY, NE, OH, PA, SC, TN, UT, WA
Page updated: Jan 10, 2026