FDA-Device2023-11-15Class II
TERUMO 60" TUBE SET W/HIGH CRACK CHK VLV, Article No. 7S3070. Singapore only. IV injection set.
B. Braun Medical, Inc.
Hazard
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.
Sold states
Worldwide distribution - US Nationwide and the countries of Canada and Singapore.
Affected count
12,800 units
Manufactured in
901 Marcon Blvd, Allentown, PA, United States
Products
TERUMO 60" TUBE SET W/HIGH CRACK CHK VLV, Article No. 7S3070. Singapore only. IV injection set.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0132-2024Don't want to check this manually?
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