Recall Z-0130-2024 ยท KYG Device, Irrigation, Ocular Surgery
B. Braun Medical, Inc.
AMO ADMINISTRATION SET, Article No. 7A3817, REF OM2505191, for ophthalmologic use.
| Date | Nov 3, 2023 (initiated Sep 26, 2023) |
| Status | Open, Classified |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981116 | SOVEREIGN CATARACT EXTRACTION SYSTEM Allergan, Inc., May 19, 1998 |