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 and Primary Set Pack convenience kit
- Product number: DYNJ52510A and DYNJ52509A
- Lot numbers: 2018090590, 2018112190, 2018090690, 2018101190, 2018101590, 2018121190, 2019013190, 2019030490, 2019040190
- Manufacturing Dates: September 21, 2018 to March 28, 2019
- Distribution Dates: October 9, 2018 to April 22, 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 Becton Dickinson (BD) Alaris Pump Infusion Sets for the Alaris Pump Model 8100.
The Medline Primary Warmer Pack and Primary Set Pack is used to aid in the administration of intravenous (IV) fluids. The Medline Primary Warmer Pack and Primary Set Pack includes several medical devices used during IV administration, including the BD Alaris Pump Infusion Set. The BD Alaris Pump Infusion Set is indicated for the delivery of fluids, including medications, blood, or blood products, into a patient’s body in a controlled manner either intravenously (IV) or through other cleared routes of administration. The Medline Primary Warmer Packs and Primary Set Packs are intended to be used by trained clinicians in inpatient units, outpatient centers, and operating rooms.
Reason for Recall
The Medline Primary Warmer Pack has been recalled because it contains the recalled BD Alaris Infusion Sets for the Alaris Pump Model 8100, due to 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. In BD’s infusion set recall, they determined that the silicone segments of the affected administration sets have non-uniform thickness. Non-uniform wall thickness can lead to non-uniform tubing collapse and can contribute to a failure to fully occlude the tubing.
While the focus of this recall is the Becton Dickenson (BD) Alaris Pump Infusion Sets in the convenience kits, the Medline Primary Warmer Pack also contains the Vyaire Medical enFlow disposable cartridge. The enFlow disposable cartridge was separately recalled by Vyaire Medical due to the potential to elute aluminum into infused fluids during use, which may expose 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, 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. FDA classified Vyaire’s Recall of the enFlow disposable cartridge as a Class 1 Recall. Medline has initiated a separate recall for the Primary Warmer Pack convenience kit which contain the Vyaire Medical enFlow disposable cartridge.
Medline Industries received four customer complaints. No serious injuries or deaths were reported.
Who May be Affected
- Patients at a St. Luke’s Health System facility who were treated with the Medline Primary Warmer Pack or Primary Set Pack convenience kit with the BD Alaris Pump Model 8100 Infusion Set
- Health care providers at a St. Luke’s Health System facility who use the Primary Warmer Pack or Primary Pack Set convenience kit with the BD Alaris Pump Model 8100 Infusion Set
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.
- Class I Device Recall Medline Industries Centurion Primary Set Pack Convenience Kit, Centurion Primary Warmer Pack Convenience Kit
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.