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

Recall Z-0925-2014 — SmartSite Needleless Connector, Model No. 2000E The SmartSite Needleless Connectors are sterile, individually packaged connectors. The connectors are used to administer fluid and medications. The needle free connector allows the user to add medication into the primary line without the use of a n

U.S. FDA — Device Enforcement · United States · 2014-01-22 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0925-2014
Date of alert
2014-01-22
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
CareFusion 303, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
13045933
Reported risk: CareFusion is recalling the SmartSite Needlefree Connector, model number 2000E, because of connection issues. The affected SmartSite connector lots may unintentionally disconnect from a female luer, may be difficult to disconnect from a female luer, or may fail to disconnect from a female luer once attached. Leakage may also be observed if the connector disconnects from the female luer during in
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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