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Open, Classified

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

FDA Recall Z-1872-2017 · Posted None

Recalling FirmCP Medical Inc
Recall StatusOpen, Classified
Product CodeGAM
Date Initiated2017-02-02
Product Quantity504 boxes/12 sutures - 6,048 individual sutures

Reason for Recall

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

Firm Action

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

Root Cause

Unknown/Undetermined by firm

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K072229MONOSWIFTCp Medical · 2007-10-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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