American Catheter / Cholangiogram Catheter 9100 Series — Class II medical device recall Z-2191-2015
Terminated recall by American Catheter Corp, reported 2015-07-29, distributed in AK, AL, CA, CO, FL, GA, HI, IL…. Catheters were not sealed before sterilization. and was not detected through subsequent acceptance activities,
| Recall number | Z-2191-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | American Catheter Corp, Ocala, FL, United States |
| Recall initiated | 2015-03-17 |
| Classified | 2015-07-22 |
| Reported by FDA | 2015-07-29 |
| Terminated | 2016-12-14 |
| Distributed | AK, AL, CA, CO, FL, GA, HI, IL, KS, LA, MI, MO, MT, NJ, OH, OK, SC, TN, TX, WA, WI |
| Quantity | 890 devices |
| Lot numbers | 14101601 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2191-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.