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

Recall Z-0916-2014 — Stand-Alone Resuscitation, T-Piece, part numbers 2063771-001, 2063772-001, 2063773-001, 2063774-001, 2063775-001, M1226442, M1241420, M1241421, M1241424, M1241425, M1241427, M1241430, M1241461, M1241463, M1241464, and M1241589; labeled in part ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 ***ww

U.S. FDA — Device Enforcement · United States · 2013-12-12 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0916-2014
Date of alert
2013-12-12
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
GE Healthcare
Product category
device
Product type
Devices
Reported risk: Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients.
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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