Recall Z-1027-2019— CP Medical Inc

Name: FDA recall Z-1027-2019
Creator: U.S. Food and Drug Administration
Published: 2019-02-04

Class II · Ongoing

Class II FDA medical device recall by CP Medical Inc, initiated 2019-02-04. It names one FDA 510(k) clearance: K001299. 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: Potential compromise of product sterility after routine monitoring for Endotoxins showed an out of limit test result..

Recalling firm: CP Medical Inc
Classification: Class II
Status: Ongoing
Initiated: 2019-02-04
Firm location: Norcross, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K001299 — PLAIN AND CHROMIC GUT ABSORBABLE SURGICAL SUTURES USPCp Medical·cleared 2000-06-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.