Class II — American Catheter Corp
| Recalling firm | AMERICAN CATHETER CORP |
|---|---|
| Registered facility | AMERICAN CATHETER CORP (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Catheters were not sealed before sterilization. and was not detected through subsequent acceptance activities, product release and distribution. |
| Product | American Catheter / Cholangiogram Catheter 9100 Series. |
| 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. |
| Initiated | 2015-03-17 |
| Classified | 2015-07-22 |
| Terminated | 2016-12-14 |
| Recall number | Z-2191-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — American Catheter Corp (Z-2191-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/71263/
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