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U.S. Department of Health and Human Services

Class 2 Device Recall PGA Suture (Visorb)

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 Class 2 Device Recall PGA Suture (Visorb)see related information
Date Initiated by FirmOctober 18, 2019
Create DateDecember 06, 2019
Recall Status1 Open3, Classified
Recall NumberZ-0655-2020
Recall Event ID 84178
510(K)NumberK002190 
Product Classification Suture, absorbable, synthetic, polyglycolic acid - Product Code GAM
ProductCoated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI: (01)10790986000657 (17)220430 (10)17050970
Code Information Product Code: 494A/494A-IMC; Lot Number: 190123-59; date of manufacture: 03/04/2019
FEI Number 3012164473
Recalling Firm/
Manufacturer		 CP Medical Inc
1775 Corporate Dr Ste 150
Norcross GA 30093-2960
For Additional Information ContactRick Goldstein
470-273-6049
Manufacturer Reason
for Recall		Failed to meet USP minimum average value for knot pull (tensile) strength.
FDA Determined
Cause 2		Under Investigation by firm
ActionAffected 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.
Quantity in Commerce174 boxes 12 per box (plus 36 samples) - total of 2124 sutures
DistributionUSA - product distributed in CA, OH, WA, PA, KY, UT, FL, TN, SC, IA, NE
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = GAM
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