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U.S. Department of Health and Human Services

Class 2 Device Recall Monoswift

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 Class 2 Device Recall Monoswiftsee related information
Date Initiated by FirmFebruary 02, 2017
Create DateApril 20, 2017
Recall Status1 Open3, Classified
Recall NumberZ-1872-2017
Recall Event ID 76875
510(K)NumberK072229 
Product Classification Suture, absorbable, synthetic, polyglycolic acid - Product Code GAM
ProductPGCL [poly (glycolide-co-caprolactone)] Absorbable Suture, Manufacturer CP Medical, Portland OR, Sterile, Product Codes L923, L459, L493, L762, L463, L922, L495, L463, L497, L494, L493
Code Information Lot Numbers - 150323-04, 150324-04, 150520-10, 150615-01, 150616-08, 150709-01, 151229-64, 160414-69, 160510-59, 160617-52, 160824-50
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		The tensile strength minimum as directed by USP <881> was not met over the length of the product's shelf life.
FDA Determined
Cause 2		Unknown/Undetermined by firm
ActionThe affected distributors/customers were contacted directly via telephone or by e-mail on February 6-7, 2017. Those end users not contacted by CP Medical directly will be contacted by their distributor
Quantity in Commerce504 boxes/12 sutures - 6,048 individual sutures
DistributionAL, AZ, AR, CA, CO, CT, FL, ID, IL, IN, KY, LA, MT, NE, NJ, NM, NY, OK, OR, SC, TX, WA and South Africa
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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