FDA Device recall Z-1596-2015
ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17
- FDA Device
- Class III
- terminated
- Published 2015-05-20
On 2015-05-20 the FDA classified a Class III recall of ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17 by Arc Medical, citing outer shipping carton was marked with an incorrect expiry date, however inner product carton was labeled correctly.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1596-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-02-19 |
| Published | 2015-05-20 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Arc Medical |
| Distribution | CA, NC |
Product
ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a humidifier in a breathing circuit.
Reason
Outer shipping carton was marked with an incorrect expiry date, however inner product carton was labeled correctly.
Identifiers
| code_info | Product code: 6160, Batch number: 110208-50 |
|---|
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-1596-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.