The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- Vyaire Medical enFlow Fluid Warming System - Disposable Cartridges
- 980200EU enFlow - Disposable Cartridge
- 980202EU enFlow - Disposable Cartridge with IV Extension Set
- Lots: All lots
- Distribution Dates: January 4, 2016 to March 7, 2019
- Devices Recalled in the U.S.: 2,899,660
- Date Initiated by Firm: March 13, 2019
The enFlow Fluid Warming System is indicated for warming blood, blood products and intravenous solutions prior to IV administration to a patient. It is intended to be used by healthcare professionals in hospital, clinical, and field environments to help prevent hypothermia. The enFlow Disposable Cartridge incorporates an aluminum extrusion. The enFlow cartridge is sterile, disposable and is used with the enFlow fluid warmer.
Reason for Recall
Vyaire Medical is recalling the Vyaire Medical enFlow Disposable Cartridges due to the potential for aluminum to elute from the warmer into the fluids, there by exposing patients to unsafe levels of aluminum.
Exposure to unsafe levels of aluminum may result in serious adverse health consequences including, but not limited to, muscle weakness, various neurocognitive and bone marrow complications, or death.
No injuries or deaths have been reported.
Who May be Affected
- Patients who undergo procedures involving the Vyaire Medical enFlow Fluid Warming System Disposable Cartridges
- Health care providers, distributors and facilities using the Vyaire Medical enFlow Fluid Warming System Disposable Cartridges
What to Do
On March 13, 2019, Viare Medical issued an initial Urgent Recall Notification. On April 29, 2019 the Urgent Recall Notification letter was updated and sent to distributors and end-users (direct and non-direct Vyaire customers), listing the following actions:
Distributors and End-Users
- Inspect current inventory on-hand. A 100% physical inventory should immediately be performed to identify and remove ALL enFlow cartridge devices from commercial distribution due to the identified potential patient safety risk(s).
- Destroy all affected product(s) in-stock in accordance with your facility's destruction protocol. If your facility does not have an alternative fluid warming system immediately available and it has been determined that the benefit(s) of the enFlow Disposable Cartridge/ Fluid Warming System outweighs the risk, refer to the Addendum for specific risk mitigative considerations before use.
- If you are not able to destroy the product on site or require further assistance, please contact Vyaire Medical at VyaireSupport2@stericycle.com or call 1-866-204-6110 for assistance.
- Complete the enclosed Customer Response Form and return it to VyaireSupport2@stericycle.com. You will receive credit for all products in the expiration date within 60 days of returning your Customer Response Form.
- If you did not purchase product direct from Vyaire, please contact your distributor to place your request for credit.
- Any adverse reactions experienced with the use of this product, and/or quality problems should be reported to Vyaire's Technical Support Department by e-mail GMB-RS-DISP-Complaint-Intake@vyaire.com or telephone at: 1-800-231-2466 prompt #1.
- If you are an end-user or distributor that has further distributed affected product to other persons or facilities, promptly communicate this recall by forwarding a copy of the updated urgent Recall Notification to those recipients and include contact information of those parties to Vyaire for tracking purposes.
- Provide instruction to persons or facilities that you further distributed affect product to requiring that all Customer Response Forms be returned to your facility, as the distributor with reconciliation responsibility.
- Vyaire will require all end-user facilities (direct and non-direct Vyaire customers) requesting on-going limited emergency use of the recalled product to return a copy of the completed Customer Response Form direct to Vyaire in addition to the facility's distributor, as noted above.
For questions or concerns regarding this notification, please call contact Vyaire's Technical Support Department by e-mail GMB-RS-DISP-Complaint-Intake@vyaire.com or telephone at: 1-800-231-2466 prompt #1.
- MHRA's Medical Device Alert issued March 19, 2019
- Perl et al. 2019. Aluminum release by coated and uncoated fluid-warming devices. Anaesthesia
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experience using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.