Dispensing Pins for Air Inlet Filter, Product Catalog No. 412005, DP2500 Dispensing Pin W/Valve....

FDA Device Recall #Z-0727-2022 — Class II — January 31, 2022

Recall Summary

Recall Number Z-0727-2022
Classification Class II — Moderate risk
Date Initiated January 31, 2022
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm B. Braun Medical, Inc.
Location Allentown, PA
Product Type Devices
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.

Lot / Code Information

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

Other Recalls from B. Braun Medical, Inc.

Recall # Classification Product Date
Z-1021-2025 Class II Design Options COMBINED SPINAL/EPIDURAL TRAY- ... Dec 4, 2024
Z-3144-2024 Class II AET36 ANESTH EXT SET - Anesthesia Extension Set... Aug 8, 2024
Z-2390-2024 Class II Infusomat UNIV. 60 DROP PUMP SET, 2 CARESITES, ... Jun 17, 2024
Z-2387-2024 Class II Infusomat SPACE PUMP IV SET, 2 CARESITES, ASV-U... Jun 17, 2024
Z-2392-2024 Class II Infusomat UNIV. 15 DROP PUMP SET, 3 CARESITE, A... Jun 17, 2024

Frequently Asked Questions

Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.