FDA recall Z-1027-2019

CP Medical Inc · Class II · device

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.

Reason for recall

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

Distribution

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

Key facts

Status
Ongoing
Initiation date
2019-02-04
Report date
2019-03-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Norcross, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1027-2019