medical Class II Updated 2019-03-27

CP Medical Inc recalls Plain and Chromic Gut Absorbable Surgical Sutures, sterile.

Recalled 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.


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Product Code (lot code): 822PG-HUF (170927-52, 180611-59); 822PG-DAR (171205-52); 810PG-1 (180924-51); 822PG-1 (180924-53)
View official government recall

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