Dispensing Pins for Air Inlet Filter, Product Catalog No. 412005, DP2500 Dispensing Pin W/Valve. A valve for aspiration or injection of medication or enteral feeding solution from inverted multi-dose vials.
Check against the official notice below — it lists the full affected range.
B. Braun Medical, Inc. is recalling Dispensing Pins for Air Inlet Filter (Product Catalog No. 412005, DP2500 Dispensing Pin W/Valve) due to an elevated risk of leakage from the Air-Inlet Filter. This valve is used for aspiration or injection of medication or enteral feeding solution. The leakage risk may result in decreased medication doses being delivered to patients, treatment delays requiring device replacement, or contamination of the fluid path that could lead to bloodstream infection.
The affected product is Lot Number 0061788969 with an expiration date of 5/31/2026. Approximately 15,550 units were distributed across the United States in Arizona, California, Florida, Louisiana, Michigan, Missouri, Mississippi, North Carolina, New Jersey, Ohio, Pennsylvania, Tennessee, Texas, and Utah, with an additional 900 units distributed in Canada. The recall record does not specify a remedy or what affected consumers should do.
Written by software from the official notice below. Not reviewed by a lawyer.
This lot may have an elevated risk of leakage from the Air-Inlet Filter of the device. Leakage of the Air-Inlet Filter may increase the risk of decreasing the dose of medication delivered to the patient, cause delays in treatment due to the need to replace the device or may cause contamination of the fluid path that can lead to bloodstream infection.
Reason for recall: This lot may have an elevated risk of leakage from the Air-Inlet Filter of the device. Leakage of the Air-Inlet Filter may increase the risk of decreasing the dose of medication delivered to the patient, cause delays in treatment due to the need to replace the device or may cause contamination of the fluid path that can lead to bloodstream infection. Distribution: US Nationwide distribution in the states of AZ, CA, FL, LA, MI, MO, MS, NC, NJ, OH, PA, TN, TX, and UT. The country of Canada. Quantity: 15,550 ea (US); 900 ea (OUS) Lot/code info: Product Code 412005 Lot Number 0061788969 Expiration date 5/31/2026 GUDID 04022495769633
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.