Date Initiated by Firm |
October 18, 2019 |
Create Date |
December 06, 2019 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0655-2020 |
Recall Event ID |
84178 |
510(K)Number |
K002190
|
Product Classification |
Suture, absorbable, synthetic, polyglycolic acid - Product Code GAM
|
Product |
Coated 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 |
Recalling Firm/ Manufacturer |
CP Medical Inc 1775 Corporate Dr Ste 150 Norcross GA 30093-2960
|
For Additional Information Contact |
Rick 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 |
Action |
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. |
Quantity in Commerce |
174 boxes 12 per box (plus 36 samples) - total of 2124 sutures |
Distribution |
USA - product distributed in CA, OH, WA, PA, KY, UT, FL, TN, SC, IA, NE |
Total Product Life Cycle |
TPLC 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) Database |
510(K)s with Product Code = GAM and Original Applicant = CP MEDICAL
|