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CP Medical Inc recalls Plain and Chromic Gut Absorbable Surgical Sutures, sterile. 12 sutures per box. Product Usage: Plain Gut Sutures are
Recalled March 27, 2019 · FDA recall Z-1027-2019 · CP Medical
Hazard
Potential compromise of product sterility after routine monitoring for Endotoxins showed an out of limit test result. · FDA Class II
Units
1,905 boxes (22,860 sutures total)
Sold at
Worldwide Distribution - US Nationwide to IA, IL, NY, SC. Distributed internationally to Canada.
Description
Potential compromise of product sterility after routine monitoring for Endotoxins showed an out of limit test result.
Product
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.
Manufacturer(s)
CP Medical Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →