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.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
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