PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: March 16, 2022 Initiated: January 31, 2022 #Z-0727-2022

Product 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.

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.

Details

Recalling Firm
B. Braun Medical, Inc.
Units Affected
15,550 ea (US); 900 ea (OUS)
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.
Location
Allentown, PA

Frequently Asked Questions

What product was recalled?
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.. Recalled by B. Braun Medical, Inc.. Units affected: 15,550 ea (US); 900 ea (OUS).
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 16, 2022. Severity: Moderate. Recall number: Z-0727-2022.