Recall Z-2570-2014— CooperSurgical, Inc.

Name: FDA recall Z-2570-2014
Creator: U.S. Food and Drug Administration
Published: 2014-07-03

Class II · Terminated

Class II FDA medical device recall by CooperSurgical, Inc., initiated 2014-07-03, terminated 2015-05-28. It names one FDA 510(k) clearance: K020951. Product: CooperSurgical H/S CATHETER (PART # 61-5007) Intended for Hysterosonography/ Hysterosalpingography.. Reason: Unsealed pouches..

Recalling firm: CooperSurgical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-07-03
Terminated: 2015-05-28
Firm location: Trumbull, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K020951 — H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MODEL 61-5007Ackrad Laboratories·cleared 2002-04-16

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

CooperSurgical H/S CATHETER (PART # 61-5007) Intended for Hysterosonography/ Hysterosalpingography.

Reason for recall

Unsealed pouches.

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