Medline Primary Warmer Pack, Product No. DYNJ52510A. The Medline Primary Warmer Pack contains the recalled Vyaire enFlow

FDA device recall Z-2066-2019 · posted 2019-08-12 · Terminated

Recall details

Recalling firm

Medline Industries Inc

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.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

N/A

Quantity affected

4,680 kits

Distribution

One distributor located in Illinois.

Date initiated

2019-05-03

Date posted

2019-08-12

Date terminated

2021-03-01

Location

Northfield, IL