Device recall: FT1000S FLUID TRANSFER SET, REF No. 356048. For direct transfer of fluids between large volume parenteral solution…
Class II FDA enforcement event 93074. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
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.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
B. Braun Medical, Inc. started this device recall on 26 Sep 2023. The firm address in the FDA record is in Allentown, PA. FDA put the recall in Class II. FDA event 93074 has 9 product records. The first FDA enforcement report date is 15 Nov 2023. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide distribution - US Nationwide and the countries of Canada and Singapore.
Recalling firm
B. Braun Medical, Inc., Allentown, PA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
9 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0128-2024 | FT1000S FLUID TRANSFER SET, REF No. 356048. For direct transfer of fluids between large volume parenteral solution containers. | 24,400 units | Class II | Ongoing | 15 Nov 2023 |
| Z-0129-2024 | SA3000 VENTED MICRO SPIKE ADAPTER, REF No. 418121, for intravenous use. | 17,100 units | Class II | Ongoing | 15 Nov 2023 |
| Z-0130-2024 | AMO ADMINISTRATION SET, Article No. 7A3817, REF OM2505191, for ophthalmologic use. | 32,000 | Class II | Ongoing | 15 Nov 2023 |
| Z-0131-2024 | 30 ML 2PORT BURETTE ASSEMBLY, Article No. 7A3950, used in a contrast management system. | 350 units | Class II | Ongoing | 15 Nov 2023 |
| Z-0132-2024 | TERUMO 60" TUBE SET W/HIGH CRACK CHK VLV, Article No. 7S3070. Singapore only. IV injection set. | 12,800 units | Class II | Ongoing | 15 Nov 2023 |
| Z-0133-2024 | THERASPHERE ADMIN SET, Article No. 7M2650. Canada only. Sterile, single use administration set used to deliver Yttrium-90 glass microspheres for internal radiation therapy. | 760 units | Class II | Ongoing | 15 Nov 2023 |
| Z-0134-2024 | ALLERGAN UNIVERSAL FILL KIT, REF No. 7M2804. for tissue expander inflation. | 27.432 units | Class II | Ongoing | 15 Nov 2023 |
| Z-0135-2024 | 30ML BURETTE ASSY WITH STOPCOCK, BNS, Article No. 7A3970. used in a contrast management system. | 400 units | Class II | Ongoing | 15 Nov 2023 |
| Z-0136-2024 | BULK LARGEBORE MALE LL FITTING, Article No. M4341750SN. IV administration component. | 175,000 units | Class II | Ongoing | 15 Nov 2023 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2023
- 917
- Share of these events in Class II
- 88%
- Product records in this event
- 9Median of the firm: 1
- Events of the firm on the register
- 90
Other events of the firm
Official channels
- FDA enforcement report Z-0128-2024The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 93074. https://recallregister.com/fda/ii/93074/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide distribution - US Nationwide and the countries of Canada and Singapore.
- What quantity of product is in FDA event 93074?
- The event has 9 product records. The first record gives this quantity:
24,400 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2023 have the same class?
- 88% of the 917 device events that started in 2023 are in Class II.