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

Recall Z-2166-2013 — Outlook Safety Infusion System Burette Set. For intravenous fluid administration.

U.S. FDA — Device Enforcement · United States · 2013-08-05 · Class II

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2166-2013
Date of alert
2013-08-05
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)
0061317318
Reported risk: Reports were received of an incorrectly assembled Outlook Safety Infusion System Burette Set (Product Code 375038), and the investigation determined that one of the ULTRASITE injection sites and corresponding low pressure backcheck valve was assembled upside down.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

Related

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.