AMO Administration SET recall
AMO ADMINISTRATION SET, Article No. 7A3817, REF OM2505191, for ophthalmologic use.
Why was AMO Administration SET 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 4046964183454 Lots 0061747706 0061752064 0061755195 0061790409
- Product
- AMO ADMINISTRATION SET, Article No. 7A3817, REF OM2505191, for ophthalmologic use.
- Recalling firm
- B. Braun Medical, Inc.
- Quantity
- 32,000
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada and Singapore.
- Recall date
- November 15, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)