Recall Z-0129-2024
B. Braun Medical, Inc. · initiated September 26, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
SA3000 VENTED MICRO SPIKE ADAPTER, REF No. 418121, for intravenous use.
Codes / lots: UDI-DI: 4046964183454 Lots 0061746019 0061755023
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.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-0129-2024
- Initiated
- September 26, 2023
- Posted by FDA
- November 3, 2023
- Product code
- FPA – Set, Administration, Intravascular
- Quantity
- 17,100 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada and Singapore.
- Recalling firm
- B. Braun Medical, Inc., Allentown, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0128-2024 Class II | FT1000S FLUID TRANSFER SET, REF No. 356048. For direct transfer of fluids between large…Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase… | 09/26/2023Open, Classified |
| Z-0130-2024 Class II | AMO ADMINISTRATION SET, Article No. 7A3817, REF OM2505191, for ophthalmologic use.Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase… | 09/26/2023Open, Classified |
| Z-0131-2024 Class II | 30 ML 2PORT BURETTE ASSEMBLY, Article No. 7A3950, used in a contrast management system.Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase… | 09/26/2023Open, Classified |
| Z-0132-2024 Class II | TERUMO 60" TUBE SET W/HIGH CRACK CHK VLV, Article No. 7S3070. Singapore only. IV…Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase… | 09/26/2023Open, Classified |
| Z-0133-2024 Class II | THERASPHERE ADMIN SET, Article No. 7M2650. Canada only. Sterile, single use…Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase… | 09/26/2023Open, Classified |
| Z-0134-2024 Class II | ALLERGAN UNIVERSAL FILL KIT, REF No. 7M2804. for tissue expander inflation.Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase… | 09/26/2023Open, Classified |
| Z-0135-2024 Class II | 30ML BURETTE ASSY WITH STOPCOCK, BNS, Article No. 7A3970. used in a contrast management…Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase… | 09/26/2023Open, Classified |
| Z-0136-2024 Class II | BULK LARGEBORE MALE LL FITTING, Article No. M4341750SN. IV administration component.Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase… | 09/26/2023Open, Classified |