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Class 2 Device Recall Monoswift |
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Date Initiated by Firm |
February 02, 2017 |
Create Date |
April 20, 2017 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1872-2017 |
Recall Event ID |
76875 |
510(K)Number |
K072229
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Product Classification |
Suture, absorbable, synthetic, polyglycolic acid - Product Code GAM
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Product |
PGCL [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
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For Additional Information Contact |
Rick Goldstein 470-273-6049
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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.
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FDA Determined Cause 2 |
Unknown/Undetermined by firm |
Action |
The 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 Commerce |
504 boxes/12 sutures - 6,048 individual sutures |
Distribution |
AL, 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 Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = GAM and Original Applicant = CP MEDICAL
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