Z-2191-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 29, 2015
- Initiation Date
- March 17, 2015
- Termination Date
- December 14, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 890 devices.
Product Description
American Catheter / Cholangiogram Catheter 9100 Series.
Reason for Recall
Catheters were not sealed before sterilization. and was not detected through subsequent acceptance activities, product release and distribution.
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.
Code Information
Product Number is 9100, Lot # 14101601.