IV Injection Set Recall: Risk of Leakage and Bloodstream Infection
B. Braun Medical is recalling 12,800 units of TERUMO IV injection sets (Lot 0061753485) due to a manufacturing defect that may cause leakage, delaying therapy and increasing risk of bloodstream infection.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall with potential for serious harm (bloodstream infection, medication exposure) but no reported illnesses, injuries, or hospitalizations. Per the rubric, recalls for risk-of-harm products without reported injury score at most 3 (High).
Plain-English summary
B. Braun Medical, Inc. is recalling 12,800 units of TERUMO 60" Tube Set with High Crack Check Valve (Article No. 7S3070, Lot 0061753485) due to a manufacturing defect that may cause leakage.
The affected product is an IV injection set distributed worldwide, including the United States, Canada, and Singapore. Leakage from the device may delay therapy, increase the risk of bloodstream infection, and expose both patients and healthcare workers to hazardous medications. In some cases, leakage could lead to life-threatening complications requiring additional medical intervention.
Patients and healthcare providers in affected areas should contact their supplier for return or replacement instructions. Monitor for signs of infection or unusual delays in intravenous therapy delivery.
The recalled product
- Product
- TERUMO 60" TUBE SET W/HIGH CRACK CHK VLV, Article No. 7S3070. Singapore only. IV injection set.
- Manufacturer
- B. Braun Medical, Inc.
- Category
- Medical Device — IV Infusion Set
- Affected units
- 12,800
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: N/A Lots 0061753485
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 recalled by B. Braun Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 9 products in this recall →Related recalls
Same manufacturer · B. Braun Medical, Inc.
See all →- LowB Braun Recalls Discofix Stopcock Sets Due to Incorrect Expiration Date
FDA (Devices) · 2026-09-09
- SevereB. Braun Recalls Lactated Ringer's Injection Due to Particulate Matter
FDA (Drugs) · 2026-09-02
- SevereDesign Options spinal trays recalled over Huons bupivacaine quality issues
FDA (Devices) · 2026-06-10
- ModerateB. Braun Shands kits contain Mastisol adhesive with cracking tubing
FDA (Devices) · 2026-06-10
- ModerateB. Braun spinal epidural kits contain Mastisol with cracking tubing
FDA (Devices) · 2026-06-10
Same hazard · leakage
See all →- HighConvaTec Esteem Body Soft Convex Urostomy Pouches Recalled for Leakage
FDA (Devices) · 2026-08-26
- SevereStryker AHTO Tube Set Packaging Recalled for Handpiece Leaking
FDA (Devices) · 2026-08-12
- SevereMedtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77522
FDA (Devices) · 2026-08-05
- HighICU Medical Recalls Hotline Fluid Warming Sets Due to Leakage Risk
FDA (Devices) · 2026-07-29
- SevereABIOMED Introducer Kit 23 Fr heart pump accessory leakage risk
FDA (Devices) · 2026-07-22