Z-2191-2015 Class II Terminated
FDA device recall Z-2191-2015 was initiated by American Catheter Corp on March 17, 2015 and is designated Class II. Reason for recall: Catheters were not sealed before sterilization. and was not detected through subsequent acceptance activities, product release and distribution. The recall status is terminated (terminated December 14, 2016). Affected quantity: 890 devices..
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.