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U.S. Department of Health and Human Services

Class 1 Device Recall Medline Primary Warmer Pack

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  Class 1 Device Recall Medline Primary Warmer Pack see related information
Date Initiated by Firm May 03, 2019
Create Date August 12, 2019
Recall Status1 Open3, Classified
Recall Number Z-2066-2019
Recall Event ID 82940
Product Classification unknown device name - Product Code N/A
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.
Code Information Lots 2018090690 2018101190 2018101590 2018121190 2019013190 2019030490 2019040190 
Recalling Firm/
Manufacturer
Medline Industries Inc
Three Lakes Drive
Northfield IL 60093
For Additional Information Contact Benjamin Gora
224-931-1884
Manufacturer 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.
FDA Determined
Cause 2
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 in Commerce 4,680 kits
Distribution One distributor located in Illinois.

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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