Recall Z-1782-2014
CooperSurgical, Inc. · initiated May 13, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Cooper Surgical TAMPA CATHETER 5 French 33 cm. Intended for Hysterosonography. Model Number: 61-2005
Codes / lots: Lot 141525
Reason for recall
Sterility of the device may be compromised due to unsealed pouch
FDA-determined cause: Process control
Action taken
Cooper Surgical Inc notified consignees by letter dated 5/13/14 sent via Federal Express with confirmed delivery receipt. Consignees are requested to return for refund or exchange. If you have any further questions contact the firm at 203.601.5200.
Details
- Recall number
- Z-1782-2014
- Initiated
- May 13, 2014
- Posted by FDA
- June 11, 2014
- Terminated
- May 28, 2015
- Product code
- LKF – Cannula, Manipulator/Injector, Uterine
- Quantity
- 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.
- Recalling firm
- CooperSurgical, Inc., Trumbull, CT