Agency classClass IIOur severity:High FDA (Devices)·Z-0727-2022·Announced 2022-03-16

B. Braun dispensing pins recalled for air filter leakage risk

B. Braun Medical is recalling dispensing pins with an elevated leakage risk in the air inlet filter. The leakage may reduce medication doses, delay treatment, or contaminate the fluid path, potentially causing bloodstream infection.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall involving a medical device with potential for serious patient harm. The hazard—air inlet filter leakage—could reduce medication doses, delay treatment, and cause bloodstream infection through fluid contamination. No illnesses or injuries have been reported, placing this in the High severity category as a risk-of-harm product without reported injury.

Plain-English summary

B. Braun Medical, Inc. is recalling one lot of Dispensing Pins for Air Inlet Filter (Catalog No. 412005, DP2500) used to aspirate or inject medication and enteral feeding solution from inverted multi-dose vials. Lot number 0061788969 with expiration date 5/31/2026 is affected. The product was distributed nationwide in the United States and Canada.

The recalled dispensing pins may have an elevated risk of leakage from the air inlet filter. This leakage can result in decreased medication doses being delivered to patients, which may delay necessary treatment. Additionally, the leakage may contaminate the fluid pathway, potentially leading to bloodstream infection.

Healthcare facilities and providers in the affected distribution areas should identify and quarantine any dispensing pins from the recalled lot. Contact B. Braun Medical, Inc. for guidance on replacement or return of affected product. Do not use dispensing pins from the recalled lot.

The recalled product

Product: 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.
Manufacturer: B. Braun Medical, Inc.
Category: Medical Device — Vial Dispensing Equipment
Hazard: leakage
dose-reduction
fluid-contamination
infection-risk

Distribution

Distributed nationwide across the United States.

The notice also names 14 states specifically:

Same manufacturer · B. Braun Medical, Inc.

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