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B. Braun Medical, Inc. Recall 89487

Description: 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.

B. Braun Medical, Inc. Recall 89487 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0727-2022
Event ID89487
Event DescriptionDispensing 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.
Product TypeDevices
DistributionUS 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.
Quantity15,550 ea (US); 900 ea (OUS)
Recall ReasonThis 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.
Device Classification20220316
Device Code InfoProduct Code 412005 Lot Number 0061788969 Expiration date 5/31/2026 GUDID 04022495769633
Center Classification Date20220307
Recall Initiation Date20220131
Recalling FirmB. Braun Medical, Inc.
Initial Notification Letter
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