Recall Z-3278-2018— CooperSurgical, Inc.

Name: FDA recall Z-3278-2018
Creator: U.S. Food and Drug Administration
Published: 2018-09-04

Class II · Terminated

Class II FDA medical device recall by CooperSurgical, Inc., initiated 2018-09-04, terminated 2020-04-15. It names one FDA 510(k) clearance: K791665. Product: Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) Product Usage: The Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) are a sterile single-use medical device providing retraction to achieve and maintain optimal visualization throughout a variety of procedures.. Reason: There is a possibility that the seal of the sterile pouch may be compromised, thereby increasing the risk of infection..

Recalling firm: CooperSurgical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-09-04
Terminated: 2020-04-15
Firm location: Trumbull, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K791665 — SCOTTS SURGICAL RETRACTOR AND ELASTICLone Star Medical Products, Inc.·cleared 1979-09-19

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

Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) Product Usage: The Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) are a sterile single-use medical device providing retraction to achieve and maintain optimal visualization throughout a variety of procedures.

Reason for recall

There is a possibility that the seal of the sterile pouch may be compromised, thereby increasing the risk of infection.

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