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

T090-000W 90" 20 Drop IV Admin Set w/2 Needlefree Y-Sites Back Check… — recall Z-2225-2016

U.S. FDA — Device Enforcement · United States · 2016-06-14 · Class II

As described by U.S. FDA — Device Enforcement: T090-000W 90" 20 Drop IV Admin Set w/2 Needlefree Y-Sites Back Check Valve. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2225-2016
Date of alert
2016-06-14
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
WalkMed Infusion, LLC
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 in the states of AL, AZ, CA, FL, IL, MA, MS, NJ, NV, NY, OH, PA, TN, UT, and WA.
Reported risk: WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.
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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