FDA-Device2017-04-26Class II
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
CP Medical Inc
Hazard
The tensile strength minimum as directed by USP <881> was not met over the length of the product's shelf life.
Sold states
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
Affected count
504 boxes/12 sutures - 6,048 individual sutures
Manufactured in
1775 Corporate Dr Ste 150, N/A, Norcross, GA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1872-2017Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief