Skip to content
Recall Observatory FDA recall evidence

Device product

TERUMO 60" TUBE SET W/HIGH CRACK CHK VLV, Article No. 7S3070. Singapore only. IV injection set.

Z-0132-2024

September 26, 2023

Class II

Product summary

Firm
B. Braun Medical, Inc.
Event
Event 93074
Status
Ongoing
Classification
Class II
Quantity
12,800 units
Official record key
device-enforcement:Z-0132-2024

Official wording

Reason: 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.

Code information: UDI-DI: N/A Lots 0061753485

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada and Singapore.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.