B. Braun AMO Administration Set Recalled for Manufacturing Defect Causing Leakage
B. Braun Medical is recalling AMO ophthalmologic administration sets due to a manufacturing defect causing potential leakage. This may delay therapy and expose patients and healthcare workers to hazardous medication.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This Class II medical device recall involves a manufacturing defect creating potential for serious harm (bloodstream infection, therapy delay, medication exposure, and life-threatening situations) without reported injuries or hospitalizations to date. It meets the 'High' severity criterion as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
B. Braun Medical, Inc. is recalling the AMO ADMINISTRATION SET (Article No. 7A3817, REF OM2505191) used in ophthalmologic procedures. The recall affects approximately 32,000 units distributed nationwide in the United States, as well as in Canada and Singapore.
The devices may leak due to a manufacturing issue. Leakage may result in a delay of therapy, increase the risk of bloodstream infection, and may expose both patients and healthcare workers to hazardous medication. There is potential for life-threatening situations that could require additional medical intervention.
The affected lots are: 0061747706, 0061752064, 0061755195, and 0061790409. Healthcare providers should discontinue use of these specific lots and contact B. Braun Medical for guidance. Patients who received therapy using these sets should consult their healthcare provider if they experience any symptoms of infection or complications.
The recalled product
- Product
- AMO ADMINISTRATION SET, Article No. 7A3817, REF OM2505191, for ophthalmologic use.
- Manufacturer
- B. Braun Medical, Inc.
- Affected units
- 32,000
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: 4046964183454 Lots 0061747706 0061752064 0061755195 0061790409
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 recalled by B. Braun Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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