Recall Z-0098-2019— CooperSurgical, Inc.

Name: FDA recall Z-0098-2019
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 2020-05-27. It names one FDA 510(k) clearance: K954311. Product: Colpo-Pneumo Occluder, Part CPO-6. Reason: 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: 2020-05-27
Firm location: Trumbull, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K954311 — KOH COLPOTOMIZER SYSTEMCooperSurgical, Inc.·cleared 1996-11-19

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

Colpo-Pneumo Occluder, Part CPO-6

Reason for recall

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.