CLASS II Device recall · Reported 16 Mar 2022 · FDA Enforcement Report

Dispensing Pins for Air Inlet Filter, Product recalled

B. Braun Medical is recalling Dispensing Pins for Air Inlet Filter, Product, distributed nationwide in the US. The recall was initiated on 31 Jan 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct Code 412005 Lot Number 0061788969 Expiration date 5/31/2026 GUDID 04022495769633

Quantity recalled15,550 ea (US); 900 ea (OUS)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0727-2022
FDA event ID: 89487
Recalling firm: B. Braun Medical, Allentown, PA
Classification: Class II
Status: Terminated
Recall initiated: 31 Jan 2022
FDA classified: 7 Mar 2022
Reported: 16 Mar 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

31 Jan 2022	Recall initiated by company
7 Mar 2022	Classified by FDA	+35 days
16 Mar 2022	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide Arizona California Florida Louisiana Michigan Missouri Mississippi North Carolina New Jersey Ohio Pennsylvania Tennessee Texas Utah

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from B. Braun Medical

All 447

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Extension Set Discofix Four Way Stopcock recalled by B Braun Medical	B Braun Medical	Other	Nationwide
3 Sep 2026Drug	ANNOUNCED	B. Braun 0.9% Sodium Chloride Injection USP, in a PAB Container recalledB. Braun	B. Braun Medical	Particulate Matter	Nationwide
2 Sep 2026Drug	CLASS I	Lactated Ringer's Injection USP Excel container recalledLactated Ringers	B Braun Medical	Particulate Matter	Nationwide
10 Jun 2026Device	CLASS I	Design Options Spinal Tray Spinal Needle Anesthesia recalled	B Braun Medical	Processing Deviation	Nationwide
10 Jun 2026Device	CLASS II	Sesk Upmc Double Catheter Tray recalled by B Braun Medical	B Braun Medical	Device Malfunction	Nationwide

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide