CP Medical Inc recalls Plain and Chromic Gut Absorbable Surgical Sutures, sterile. 12 sutures per box. Product Usage: Plain Gut Sutures are in…

Recall date

February 4, 2019

Source

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

Recall number

Z-1027-2019

FDA classification

Class II

Brand / firm

CP Medical Inc

Sold / distributed

Worldwide Distribution - US Nationwide to IA, IL, NY, SC. Distributed internationally to Canada.

Why it was recalled

Potential compromise of product sterility after routine monitoring for Endotoxins showed an out of limit test result.

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

What was recalled

Plain and Chromic Gut Absorbable Surgical Sutures, sterile. 12 sutures per box. Product Usage: Plain Gut Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neural tissues.