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.
- Primary Warmer Pack convenience kit
- Product number: DYNJ52510A
- Lot numbers: 2018090690, 2018101190, 2018101590, 2018121190, 2019013190, 2019030490, 2019040190
- Manufacturing Dates: September 21, 2018 to April 17, 2019
- Distribution Dates: October 9, 2018 to March 28, 2019
- Devices Recalled in the U.S.: 4,680
- Date Initiated by Firm: March 20, 2019
The affected product was only distributed to St. Luke’s Health System in Idaho.
Note: This recall is associated with the recall of the Vyaire Medical enFlow Fluid Warming System Disposable Cartridges recall.
The Medline Primary Warmer Pack is used to aid in the administration of intravenous (IV) fluids. The Medline Primary Warmer Pack includes several medical devices used during IV administration, including the Vyaire Medical enFlow Disposable Cartridge. The enFlow Disposable Cartridge is used for warming blood, blood products, and intravenous solutions prior to administration of these fluids to help prevent hypothermia. The Medline Primary Warmer Packs are intended to be used by trained clinicians in inpatient units, outpatient centers, and operating rooms.
Reason for Recall
Medline is recalling the Primary Warmer Pack because it contains the recalled Vyaire Medical enFlow Disposable Cartridge, which may elute aluminum into infused fluids during use, potentially exposing patients to unsafe aluminum levels. Continued use of these products may result in prolonged, undetected aluminum exposure and toxicity, which could lead to neurocognitive complications (including an inability to concentrate, remember things, process information, learn, speak, and understand), bone marrow complications, or death. The use of affected product may cause serious adverse health consequences, which may not be immediately linked to the affected product due to lack of awareness. Thus, signs and symptoms may be attributed to pre-existing illnesses or comorbidities as well as their respective treatments. Medline Industries received four customer complaints. No serious injuries or deaths were reported.
While the focus of this recall is the Vyaire Medical enFlow disposable cartridge in the convenience kits, the Medline Primary Warmer Pack also contains the Becton Dickenson (BD) Alaris Pump Model 8100 Infusion Set. BD separately recalled this Infusion Set due to non-uniform wall thickness of the silicone segments of the affected administration sets, which can lead to non-uniform tubing collapse and can contribute to a failure to fully occlude the tubing. Therefore, there is the potential for faster than expected delivery of medication (over-infusion) or an unintended delivery that occurs while the pump is not in a “running” status. The FDA classified BD’s recall of the Alaris Pump Model 8100 Infusion Set as a Class 1 Recall. Also, Medline has initiated a separate recall for the Medline Primary Warmer Packs, which contain the BD Alaris Infusion Pump Administration Set.
Who May be Affected
- Patients at a St. Luke’s Health System facility in Idaho who were treated with the Medline Primary Warmer Pack.
- Health care providers at a St. Luke’s Health System facility in Idaho who use the Primary Warmer Pack convenience kit with Vyaire Medical enFlow Fluid Warming System.
What to Do
On July 2, 2019, the firm sent a letter to customers instructing them to:
- Identify all inventory in their possession
- Cease further distribution immediately
- Notify all facilities to whom this product may have been further distributed and advise them to cease use immediately.
- Complete an accountability record and fax or email as soon as possible.
- Customers with questions about this recall can contact the Medline RA Associate/Recalls at 224-931-1884 x7701884 or 1 Medline Pl, Mundelein, IL 60060-4486.
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 to 1-800-FDA-0178.