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
- Company
- Cp Medical Inc
- Recall Initiated
- February 2, 2017
- Recall Number
- Z-1872-2017
- Quantity
- 504 boxes/12 sutures - 6,048 individual sutures
- Firm Location
- Norcross, GA
Reason for Recall
The tensile strength minimum as directed by USP <881> was not met over the length of the product's shelf life.
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
Lot / Code Info
Lot Numbers - 150323-04, 150324-04, 150520-10, 150615-01, 150616-08, 150709-01, 151229-64, 160414-69, 160510-59, 160617-52, 160824-50
Root Cause
Unknown/Undetermined by firm
Action Taken
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