FDA Medical Device Recalls (openFDA)
Medline Industries Inc: 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.
- Recall number
- Z-2066-2019
- Recalling firm
- Medline Industries Inc
- 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.
- Status
- Terminated
- Initiated
- 2019-05-03
- Posted
- 2019-08-12
- Terminated
- 2021-03-01
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- The firm notified its distributor, Medline, of the recall via Urgent Product Recall Notice. The distributor was asked to identify all inventory within its possession and to cease distribution immediately. The distributor was also asked to forward a copy of the notice to any customers to whom the product may have been further distributed. Medline notified customers in a letter dated March 20, 2019, titled "VYAIRE MEDICAL SUB-RECALL IMMEDIATE ACTION REQUIRED". Customers were instructed to do the following: 1. Immediately check your stock for the specific kit number and the affected kit lot number (attached list). Quarantine any kits with the listed lot numbers. If you dont have any of the lots listed above skip to step 3. 2. Affix the enclosed stickers on the affected kits and return to stock. If additional stickers are needed please call 866-359-1704. Please be sure NOT to use the recalled enFlow Disposable Cartridge components, pull another approved product from sterile supply. 3. Please fill out and return the enclosed Verification Form via email to recalls@medline.com or fax 866-767-1290. Customers with questions should contact the firm at 1-866-359-1704.
- Quantity
- 4,680 kits
- Distribution
- One distributor located in Illinois.
- Lot, serial or model codes
- Lots 2018090690 2018101190 2018101590 2018121190 2019013190 2019030490 2019040190
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- N/A
- Firm FEI
- 1417592
- Firm city
- Northfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28