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

Transpac IV Monitoring Kit with 03 ml Squeeze Flush, SafeSet… — recall Z-2826-2016

U.S. FDA — Device Enforcement · United States · 2016-08-10 · Class II

As described by U.S. FDA — Device Enforcement: Transpac IV Monitoring Kit with 03 ml Squeeze Flush, SafeSet Reservoir, 2 Needleless Valves, Mounts and Bracket, Item Nos. 46107-35, 46110-07 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressu

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2826-2016
Date of alert
2016-08-10
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
ICU Medical, Inc.
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
US Nationwide Distribution
Reported risk: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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