Device product
CooperSurgical H/S CATHETER (PART # 61-5007) Intended for Hysterosonography/ Hysterosalpingography.
Z-2570-2014
Product summary
- Event
- Event 68754
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,400 units
- Official record key
device-enforcement:Z-2570-2014
Official wording
Reason: Unsealed pouches.
Code information: Lot 153914
Distribution pattern: Worldwide Distribution -- USA, in the states of CA, TX, IL, MI, MS, ID, NY, FL, MD, PA, OR, GA, CO, WA, NJ, HI, and NC, including DC; and the countries of the countries of Spain, England, Holland, and United Kingdom.
Derived failure modes
-
Unknown
Unsealed pouches.