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Recall Observatory FDA recall evidence

Device 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.

Z-0727-2022

January 31, 2022

Class II

Product summary

Firm
B. Braun Medical, Inc.
Event
Event 89487
Status
Terminated
Classification
Class II
Quantity
15,550 ea (US); 900 ea (OUS)
Official record key
device-enforcement:Z-0727-2022

Official wording

Reason: 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.

Code information: Product Code 412005 Lot Number 0061788969 Expiration date 5/31/2026 GUDID 04022495769633

Distribution pattern: 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.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    contamination of the fluid path that can lead