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Use caution Medical device recall · FDA · Published September 26, 2023

B. Braun Medical Singapore IV Tube Set Recall: Leakage Risk

B. Braun Medical recalls Singapore-only 60" IV tube sets with potential leakage causing infection or delayed therapy. Affected units include specific lot numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0132-2024Medical deviceB. Braun ›
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Contact the company

Recalling firmB. Braun Medical, Inc.901 Marcon Blvd · Allentown, PA 18109-9512
✎ GovInfoNow plain-language explainer

B. Braun Medical is recalling certain IV tube sets sold in Singapore due to a manufacturing issue that may cause leakage. This leakage could delay treatment, increase infection risk, and potentially lead to serious health issues. Read more at govinfonow.com/recall/57230-b-braun-medical-singapore-iv-tube-set-recall-leakage-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/57230-b-braun-medical-singapore-iv-tube-set-recall-leakage-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0132-2024

Cite this page

“B. Braun Medical Singapore IV Tube Set Recall: Leakage Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/57230-b-braun-medical-singapore-iv-tube-set-recall-leakage-risk. Based on FDA recall #Z-0132-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0132-2024%22&limit=1).

The FDA announced on September 26, 2023, that B. Braun Medical, Inc. is recalling TERUMO 60" TUBE SET W/HIGH CRACK CHK VLV, Article No. 7S3070, due to potential leakage. The agency stated the recall affects units distributed in the United States, Canada, and Singapore.

How to tell if you have it

  • Brand: B. Braun
  • Product: TERUMO 60" TUBE SET W/HIGH CRACK CHK VLV
  • Article No.: 7S3070
  • Lot codes: 0061753485
  • Quantity: 12,800 units

The hazard

According to the 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.

Context

GovInfoNow's records show B BRAUN MEDICAL INC has 66 other recalls on record since 2013-10-15. Recent brand recalls include a 2026-08-19 recall for 100mL Sodium Chloride Injection due to particulate matter, a 2026-08-12 recall for Lactated Ringer's Injection for particulate matter, and a 2026-08-04 recall for Discofix Four Way Stopcock sets due to incorrect expiration dates. Other recent recalls of similar products include Stryker Single Spike Tube Set Leaks During Use (2026-06-08), Becton Dickinson Swan-Ganz Jr Catheter Recall: Leaking Hub Risk (2026-04-08), and Stryker AHTO Tube Set Leaking During Use (2026-06-08).

How to tell if you have this one

Check for the product name 'TERUMO 60" TUBE SET W/HIGH CRACK CHK VLV' with Article No. 7S3070. The recall applies to specific lot numbers sold in Singapore.

  • Brand
    B. Braun
  • Category
    Medical device
FDA recall event · 9 products

All 9 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    Worldwide distribution - US Nationwide and the countries of Canada and Singapore.
Recall numberProduct, codes & lotsQuantity
Z-0128-2024FT1000S FLUID TRANSFER SET, REF No. 356048. For direct transfer of fluids between large volume parenteral solution containers.; UDI-DI: 4022495769558 Lots 0061755752, 0061761812, 006176627924,400 units
Z-0129-2024SA3000 VENTED MICRO SPIKE ADAPTER, REF No. 418121, for intravenous use.; UDI-DI: 4046964183454 Lots 0061746019 006175502317,100 units
Z-0130-2024AMO ADMINISTRATION SET, Article No. 7A3817, REF OM2505191, for ophthalmologic use.; UDI-DI: 4046964183454 Lots 0061747706 0061752064 0061755195 006179040932,000
Z-0131-202430 ML 2PORT BURETTE ASSEMBLY, Article No. 7A3950, used in a contrast management system.; UDI-DI: N/A Lots 0061766049350 units
Z-0132-2024TERUMO 60" TUBE SET W/HIGH CRACK CHK VLV, Article No. 7S3070. Singapore only. IV injection set.; UDI-DI: N/A Lots 006175348512,800 units
Z-0133-2024THERASPHERE ADMIN SET, Article No. 7M2650. Canada only. Sterile, single use administration set used to deliver Yttrium-90 glass microspheres for internal radiation therapy.; UDI-DI: 5060116920635 Lot 0061790166760 units
Z-0134-2024ALLERGAN UNIVERSAL FILL KIT, REF No. 7M2804. for tissue expander inflation.; UDI-DI: 4046964823749 Lot 0061745499, 0061745500, 0061745501, 006179277027.432 units
Z-0135-202430ML BURETTE ASSY WITH STOPCOCK, BNS, Article No. 7A3970. used in a contrast management system.; UDI-DI: N/A Lots 0061742253 0061751732400 units
Z-0136-2024BULK LARGEBORE MALE LL FITTING, Article No. M4341750SN. IV administration component.; UDI-DI: N/A Lot 0061744741, 0061749486175,000 units
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Identify the product name and article number to confirm if it matches the recalled items.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Worldwide distribution - US Nationwide and the countries of Canada and Singapore.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 50 days after the firm started it.

1. Firm started the recall: Sep 26, 202312. FDA classified it Class II: Nov 3, 202323. Published in FDA’s Enforcement Report: Nov 15, 202332023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0132-2024 (September 26, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0132-2024 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA