Z-1872-2017 Class II Ongoing
FDA device recall Z-1872-2017 was initiated by CP Medical Inc on February 2, 2017 and is designated Class II. Reason for recall: The tensile strength minimum as directed by USP <881> was not met over the length of the product's shelf life. The recall status is ongoing. Affected quantity: 504 boxes/12 sutures - 6,048 individual sutures.
Recall Details
- Product Type
- Devices
- Report Date
- April 26, 2017
- Initiation Date
- February 2, 2017
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 504 boxes/12 sutures - 6,048 individual sutures
Product Description
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
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 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
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