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

Recall Z-1661-2015 — Direct Water feed Kit, Catalog#10373222

U.S. FDA — Device Enforcement · United States · 2015-03-05 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1661-2015
Date of alert
2015-03-05
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Siemens Medical Solutions Diagnostics
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10373222
Reported risk: The bottle assemblies were manufactured with a quality issue where in some cases the smaller diameter opening on both IMMULITE 2000 and IMMULITE 2000XPi Water Bottles and Liquid Waste Bottles is undersized and/or deformed, preventing the cap from closing or fastening securely to the bottle.
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.

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