—#173166

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.

FDA product code: N/A
Affected lot / code info: Lots 2018090690 2018101190 2018101590 2018121190 2019013190 2019030490 2019040190

Why it was recalled

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 (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Medline Industries Inc
Address: Three Lakes Drive, Northfield, Illinois 60093

Distribution

Distribution pattern: One distributor located in Illinois.

Timeline

Recall initiated: 2019-05-03
Posted by FDA: 2019-08-12
Terminated: 2021-03-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #173166. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.