Device 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
Z-1872-2017
Product summary
- Firm
- CP Medical Inc
- Event
- Event 76875
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 504 boxes/12 sutures - 6,048 individual sutures
- Official record key
device-enforcement:Z-1872-2017
Official wording
Reason: The tensile strength minimum as directed by USP <881> was not met over the length of the product's shelf life.
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
Distribution pattern: 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
Derived failure modes
-
Unknown
The tensile strength minimum as directed by USP <881> was not met over the length of the product's shelf life.