FDA Medical Device Recalls (openFDA)
B. Braun Medical, Inc.: AMO ADMINISTRATION SET, Article No. 7A3817, REF OM2505191, for ophthalmologic use.
- Recall number
- Z-0130-2024
- Recalling firm
- B. Braun Medical, Inc.
- Product
- AMO ADMINISTRATION SET, Article No. 7A3817, REF OM2505191, for ophthalmologic use.
- Status
- Open, Classified
- Initiated
- 2023-09-26
- Posted
- 2023-11-03
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Process control
- Action
- On September 26, 2023, the firm notified customers via Urgent Product Recall Notification letters. Customers were informed of the potential for leakage at the male Luer lock site. Customers were instructed to report total amount of impacted product on hand to the firm, after which B Braun Customer Support will contact the customer with instructions on how to return the product for credit or replacement depending on the customer's need. Questions about this recall may be reported to BBMI s Postmarket Surveillance Department by calling 1-833-425-1464.
- Quantity
- 32,000
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada and Singapore.
- Lot, serial or model codes
- UDI-DI: 4046964183454 Lots 0061747706 0061752064 0061755195 0061790409
- 510(k) numbers
- ["K981116"]
- PMA numbers
- not on file
- Product code
- KYG
- Firm FEI
- 2523676
- Firm city
- Allentown
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28