CLASS II ONGOING Device recall · Reported 15 Nov 2023 · FDA Enforcement Report

AMO Administration SET, Article No. 7A3817 recalled by B. Braun Medical

B. Braun Medical is recalling AMO Administration SET, Article No. 7A3817, distributed nationwide in the US. The recall was initiated on 26 Sep 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: 4046964183454 Lots 0061747706 0061752064 0061755195 0061790409

Quantity recalled32,000

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-0130-2024
FDA event ID: 93074
Recalling firm: B. Braun Medical, Allentown, PA
Classification: Class II
Status: Ongoing
Recall initiated: 26 Sep 2023
FDA classified: 3 Nov 2023
Reported: 15 Nov 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Infusion Pumps

Timeline

26 Sep 2023	Recall initiated by company
3 Nov 2023	Classified by FDA	+38 days
15 Nov 2023	Published in enforcement report	+12 days

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

Reason for recall

Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to hazardous medication. There is also the potential for life-threatening situations to occur requiring additional medical intervention.

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

AMO ADMINISTRATION SET, Article No. 7A3817, REF OM2505191, for ophthalmologic use.

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Canada and Singapore.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI-DI: 4046964183454 Lots 0061747706 0061752064 0061755195 0061790409

Where was it sold?

Worldwide distribution - US Nationwide and the countries of Canada and Singapore.

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.

Other products in this recall event

8 other products · FDA event 93074

This product is part of a recall event; the main page for the event is Terumo 60" Tube Set W/High Crack Chk Vlv, Article No. 7S3070 recalled.

Reported	Class	Recall	Company	Reason	Where
15 Nov 2023	CLASS II	Terumo 60" Tube Set W/High Crack Chk Vlv, Article No. 7S3070 recalled	B. Braun Medical	Packaging Defects	Nationwide
15 Nov 2023	CLASS II	Therasphere Admin Set, Article No. 7M2650 recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
15 Nov 2023	CLASS II	2PORT Burette Assembly, Article No. 7A3950, used recalled	B. Braun Medical	Packaging Defects	Nationwide
15 Nov 2023	CLASS II	Burette Assy With Stopcock, Bns, Article No. 7A3970 recalled	B. Braun Medical	Packaging Defects	Nationwide
15 Nov 2023	CLASS II	Allergan Universal Fill Kit recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
15 Nov 2023	CLASS II	Ft1000s Fluid Transfer Set recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
15 Nov 2023	CLASS II	Sa3000 Vented Micro Spike Adapter recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
15 Nov 2023	CLASS II	Bulk Largebore Male LL Fitting, Article No. M4341750SN recalled	B. Braun Medical	Packaging Defects	Nationwide

More recalls from B. Braun Medical

All 448

Reported	Class	Recall	Company	Reason	Where
28 Oct 2026Device	CLASS II	B Braun Safsite Injection Site, RV1000NC Safsite Valve W/O Extra Cap recalled	B Braun Medical	Packaging Defects	Nationwide
16 Sep 2026Drug	CLASS I	0.9% Sodium Chloride Injection, USP Partial Fill recalledSodium Chloride	B Braun Medical	Particulate Matter	Nationwide
9 Sep 2026Device	CLASS II	Extension Set Discofix Four Way Stopcock recalled by B Braun Medical	B Braun Medical	Other	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

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All 549

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23 Sep 2026Device	CLASS II	IV Non-Dedicated Gravity Administration Sets with drip chambers recalled	ICU Medical	Foreign Material	Nationwide
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9 Sep 2026Device	CLASS II	Baxter Novum IQ Syringe Pump, Loaner recalled by Baxter Healthcare	Baxter Healthcare	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Baxter Novum IQ Syringe Pump recalled by Baxter Healthcare	Baxter Healthcare	Device Malfunction	Nationwide