Device product
Cooper Surgical TAMPA CATHETER 5 French 33 cm. Intended for Hysterosonography. Model Number: 61-2005
Z-1782-2014
Product summary
- Event
- Event 68317
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1180 units
- Official record key
device-enforcement:Z-1782-2014
Official wording
Reason: Sterility of the device may be compromised due to unsealed pouch
Code information: Lot 141525
Distribution pattern: 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.
Derived failure modes
-
Labeling or packaging
unsealed pouch