Recall Z-2066-2019— Medline Industries Inc
Class I · Terminated
Class I FDA medical device recall by Medline Industries Inc, initiated 2019-05-03, terminated 2021-03-01. FDA's recall record names no specific 510(k) clearance for this event. 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: 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..
- Recalling firm
- Medline Industries Inc
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2019-05-03
- Terminated
- 2021-03-01
- Firm location
- Northfield, IL, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.