Z-2066-2019Class I

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

Name: Z-2066-2019 Medline Primary Warmer Pack, Product No. DYNJ52510A. The Medline Primary Warmer Pack contains the recalled...
Creator: Medline Industries Inc
Published: 2019-05-03
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2019-05-03 / Terminated / root cause: manufacturing process

FDA source

Medline Industries Inc began a recall of Medline Primary Warmer Pack, Product No. DYNJ52510A. The Medline Primary Warmer Pack contains the recalled Vyaire enFlow Disposable Cartridge, which is the... on 2019-05-03. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2066-2019
Classification: Class I
Status: Terminated
Initiated: 2019-05-03
Posted: 2019-08-12
Terminated: 2021-03-01
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
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.
Product code: N/A
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.
Root cause tag: manufacturing process
FDA 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 [email protected] or fax 866-767-1290. Customers with questions should contact the firm at 1-866-359-1704.
Quantity in commerce: 4,680 kits
Distribution: One distributor located in Illinois.
Product codes and lots: Lots 2018090690 2018101190 2018101590 2018121190 2019013190 2019030490 2019040190

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2066-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2066-2019	Class I	Terminated	Voluntary: Firm initiated	2019-08-21	2019-08-12

Product code N/A

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)