Z-0727-2022 Class II Terminated
FDA device recall Z-0727-2022 was initiated by B. Braun Medical, Inc. on Jan 31, 2022 and is designated Class II. 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… The recall status is terminated (terminated Apr 29, 2024). Affected quantity: 15,550 ea (US); 900 ea (OUS).
Recall Details
- Product Type
- Devices
- Report Date
- Mar 16, 2022
- Initiation Date
- Jan 31, 2022
- Termination Date
- Apr 29, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15,550 ea (US); 900 ea (OUS)
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.
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.
Code Information
Product Code 412005 Lot Number 0061788969 Expiration date 5/31/2026 GUDID 04022495769633
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0727-2022
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026