CLASS II ONGOING Device recall · Reported 15 Nov 2023 · FDA Enforcement Report
Bulk Largebore Male LL Fitting, Article No. M4341750SN recalled
B. Braun Medical is recalling Bulk Largebore Male LL Fitting, Article No. M4341750SN, 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
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-0136-2024
- 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
- Other Medical Devices
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
BULK LARGEBORE MALE LL FITTING, Article No. M4341750SN. IV administration component.
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Canada and Singapore.
Questions about this recall
Is Bulk Largebore Male LL Fitting, Article No. M4341750SN recalled?
Yes. B. Braun Medical recalled Bulk Largebore Male LL Fitting, Article No. M4341750SN on 26 Sep 2023. The recall is Class II and its status is Ongoing. Recall number Z-0136-2024.
Why was it recalled?
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.
Which lots are affected?
UDI-DI: N/A Lot 0061744741, 0061749486
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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