ThermoFlo 1 HME — Class III medical device recall Z-1596-2015
Terminated recall by Arc Medical Inc, reported 2015-05-20, distributed in CA, NC. Outer shipping carton was marked with an incorrect expiry date, however inner product carton was labeled corre
| Recall number | Z-1596-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Arc Medical Inc, Tucker, GA, United States |
| Recall initiated | 2015-02-19 |
| Classified | 2015-05-08 |
| Reported by FDA | 2015-05-20 |
| Terminated | 2017-08-29 |
| Distributed | CA, NC |
| Quantity | 1,810 units |
| Reason classes | labeling |
| Lot numbers | 110208-50 |
Product
ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a humidifier in a breathing circuit.
Reason for recall
Outer shipping carton was marked with an incorrect expiry date, however inner product carton was labeled correctly.
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-1596-2015. 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.