FDA Device recall Z-2191-2015
American Catheter / Cholangiogram Catheter 9100 Series
- FDA Device
- Class II
- terminated
- Published 2015-07-29
On 2015-07-29 the FDA classified a Class II recall of American Catheter / Cholangiogram Catheter 9100 Series by American Catheter, citing catheters were not sealed before sterilization. and was not detected through subsequent acceptance activities, product release and distribution.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2191-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-03-17 |
| Published | 2015-07-29 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | American Catheter |
| Distribution | AK, AL, CA, CO, FL, GA, HI, IL, KS, LA, MI, MO, MT, NJ, OH, OK, SC, TN, TX, WA, WI |
Product
American Catheter / Cholangiogram Catheter 9100 Series.
Reason
Catheters were not sealed before sterilization. and was not detected through subsequent acceptance activities, product release and distribution.
Identifiers
| code_info | Product Number is 9100, Lot # 14101601. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2191-2015%22
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