Device 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.
Z-2066-2019
Product summary
- Event
- Event 82940
- Status
- Terminated
- Classification
- Class I
- Quantity
- 4,680 kits
- Official record key
device-enforcement:Z-2066-2019
Official wording
Reason: 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.
Code information: Lots 2018090690 2018101190 2018101590 2018121190 2019013190 2019030490 2019040190
Distribution pattern: One distributor located in Illinois.
Derived failure modes
-
Unknown
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.