CP Medical Inc recalls PGCL [poly (glycolide-co-caprolactone)] Absorbable Suture, Manufacturer CP Medical, Portland OR, Sterile, Product Codes…

Recall date

February 2, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1872-2017

FDA classification

Class II

Brand / firm

CP Medical Inc

Sold / distributed

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

Why it was recalled

The tensile strength minimum as directed by USP <881> was not met over the length of the product's shelf life.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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