Recall Z-0727-2022— B. Braun Medical, Inc.
Class II · Terminated
Class II FDA medical device recall by B. Braun Medical, Inc., initiated 2022-01-31, terminated 2024-04-29. It names 2 FDA 510(k) clearances: K942988, K925401. 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.. 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..
- Recalling firm
- B. Braun Medical, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2022-01-31
- Terminated
- 2024-04-29
- Firm location
- Allentown, PA, United States
510(k) clearances named in this recall
2 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.