Z-2066-2019 Class I Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 21, 2019
- Initiation Date
- May 3, 2019
- Termination Date
- March 1, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,680 kits
Product Description
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.
Distribution Pattern
One distributor located in Illinois.
Code Information
Lots 2018090690 2018101190 2018101590 2018121190 2019013190 2019030490 2019040190