Recall Z-1782-2014— CooperSurgical, Inc.

Name: FDA recall Z-1782-2014
Creator: U.S. Food and Drug Administration
Published: 2014-05-13

Class II · Terminated

Class II FDA medical device recall by CooperSurgical, Inc., initiated 2014-05-13, terminated 2015-05-28. It names one FDA 510(k) clearance: K970492. Product: Cooper Surgical TAMPA CATHETER 5 French 33 cm. Intended for Hysterosonography. Model Number: 61-2005. Reason: Sterility of the device may be compromised due to unsealed pouch.

Recalling firm: CooperSurgical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-05-13
Terminated: 2015-05-28
Firm location: Trumbull, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K970492 — INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETERAckrad Laboratories·cleared 1997-04-09

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

Cooper Surgical TAMPA CATHETER 5 French 33 cm. Intended for Hysterosonography. Model Number: 61-2005

Reason for recall

Sterility of the device may be compromised due to unsealed pouch

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