Medline Primary Warmer Pack — Class I medical device recall Z-2066-2019
Terminated recall by Medline Industries Inc, reported 2019-08-21, distributed in IL. The Vyaire enFlow disposable cartridge was recalled due to the potential for unsafe aluminum levels to elute i
| Recall number | Z-2066-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries Inc, Northfield, IL, United States |
| Recall initiated | 2019-05-03 |
| Classified | 2019-08-12 |
| Reported by FDA | 2019-08-21 |
| Terminated | 2021-03-01 |
| Distributed | IL |
| Quantity | 4,680 kits |
| Reason classes | device malfunction |
| Lot numbers | 2018090690, 2018101190, 2018101590, 2018121190, 2019013190, 2019030490, 2019040190 |
Product
Medline Primary Warmer Pack, Product No. DYNJ52510A. The Medline Primary Warmer Pack contains the recalled Vyaire enFlow Disposable Cartridge, which is the subject of this recall, and the recalled BD Alaris Pump Infusion Set (RES#82951) Product Usage: The Vyaire enFlow Disposable Cartridges contain a heating element that is used to help raise or maintain a patient's body temperature.
Reason for recall
The Vyaire enFlow disposable cartridge was recalled due to the potential for unsafe aluminum levels to elute into the infusate. The Use of the BD Alaris Pump Infusion Set may lead to serious adverse events for patients due to the incomplete occlusion caused by variation in tubing wall thickness.
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-2066-2019. 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.