Device product
American Catheter / Cholangiogram Catheter 9100 Series.
Z-2191-2015
Product summary
- Event
- Event 71263
- Status
- Terminated
- Classification
- Class II
- Quantity
- 890 devices.
- Official record key
device-enforcement:Z-2191-2015
Official wording
Reason: Catheters were not sealed before sterilization. and was not detected through subsequent acceptance activities, product release and distribution.
Code information: Product Number is 9100, Lot # 14101601.
Distribution pattern: Distributed in the states of AL, AK, CA, CO, FL, GA, HI, IL, KS, LA, MI, MO, MT, NJ, OH, OK, SC, TN, TX, WA, and WI.
Derived failure modes
-
Unknown
Catheters were not sealed before sterilization. and was not detected through subsequent acceptance activities, product release and distribution.