Recall Z-2191-2015 ยท GBZ Catheter, Cholangiography
American Catheter Corp
American Catheter / Cholangiogram Catheter 9100 Series.
| Date | Jul 22, 2015 (initiated Mar 17, 2015) |
| Status | Terminated |
| Reason | Catheters were not sealed before sterilization. and was not detected through subsequent acceptance activities, product release and distribution. |
| Root cause | Process control |
| Action | Consignees were contacted by telephone of the affected lot number and sent a Recall Script dated 3/17/2015 giving instructions how to respond to this recall. |
| Quantity | 890 devices. |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.