Medline Primary Warmer Pack Recalled for Unsafe Aluminum Levels
Medline Industries is recalling 4,680 Primary Warmer Packs because the included Vyaire enFlow cartridge may release unsafe aluminum levels into the infusate.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states that the use of the BD Alaris Pump Infusion Set may lead to serious adverse events for patients, which aligns with the rubric criterion for 'significant injury/property-damage reports' or risk of serious harm.
Plain-English summary
Medline Industries Inc is recalling 4,680 kits of the Medline Primary Warmer Pack, Product No. DYNJ52510A. The recall is driven by the inclusion of the Vyaire enFlow Disposable Cartridge, which was previously recalled due to the potential for unsafe aluminum levels to elute into the infusate. The Vyaire enFlow Disposable Cartridges contain a heating element used to help raise or maintain a patient's body temperature.
The Medline Primary Warmer Pack also contains the recalled BD Alaris Pump Infusion Set (RES#82951). The use of this infusion set may lead to serious adverse events for patients due to incomplete occlusion caused by variation in tubing wall thickness.
The affected lots are 2018090690, 2018101190, 2018101590, 2018121190, 2019013190, 2019030490, and 2019040190. The products were distributed to one distributor located in Illinois. Consumers and healthcare facilities should stop using the affected products and contact Medline Industries Inc for further instructions.
The recalled product
- 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…
- Manufacturer
- Medline Industries Inc
- Affected units
- 4,680
Distribution
Distributed in 1 state:
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