Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0132-2024 — TERUMO 60" TUBE SET W/HIGH CRACK CHK VLV, Article No. 7S3070. Singapore only. IV injection set.

U.S. FDA — Device Enforcement · United States · 2023-09-26 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0132-2024
Date of alert
2023-09-26
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
B. Braun Medical, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
0061753485
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.