AMO ADMINISTRATION SET, Article No. 7A3817, REF OM2505191, for ophthalmologic use.
Reported: November 15, 2023 Initiated: September 26, 2023 #Z-0130-2024
Product Description
AMO ADMINISTRATION SET, Article No. 7A3817, REF OM2505191, for ophthalmologic use.
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.
Details
- Recalling Firm
- B. Braun Medical, Inc.
- Units Affected
- 32,000
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada and Singapore.
- Location
- Allentown, PA
Frequently Asked Questions
What product was recalled? ▼
AMO ADMINISTRATION SET, Article No. 7A3817, REF OM2505191, for ophthalmologic use.. Recalled by B. Braun Medical, Inc.. Units affected: 32,000.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on November 15, 2023. Severity: Moderate. Recall number: Z-0130-2024.
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