PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: June 18, 2014 Initiated: May 13, 2014 #Z-1782-2014

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

Details

Recalling Firm
CooperSurgical, Inc.
Units Affected
1180 units
Distribution
Distributed USA (nationwide) including the states of CO, CT, MO, VT, NY, OH, NJ, FL, NC, VA, AL, MA, PA, and CA, and the country of Canada.
Location
Trumbull, CT

Frequently Asked Questions

What product was recalled?
Cooper Surgical TAMPA CATHETER 5 French 33 cm. Intended for Hysterosonography. Model Number: 61-2005. Recalled by CooperSurgical, Inc.. Units affected: 1180 units.
Why was this product recalled?
Sterility of the device may be compromised due to unsealed pouch
Which agency issued this recall?
This recall was issued by the FDA Devices on June 18, 2014. Severity: Moderate. Recall number: Z-1782-2014.