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

6" (15 cm) Appx 0.26 ml, Smallbore Ext Set with NanoClave… — recall Z-0659-2014

U.S. FDA — Device Enforcement · United States · 2013-12-24 · Class II

As described by U.S. FDA — Device Enforcement: 6" (15 cm) Appx 0.26 ml, Smallbore Ext Set with NanoClave T-Connector, Clamp, Luer Slip, Part No. A1000, Item No. 011-A1002 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of flu

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0659-2014
Date of alert
2013-12-24
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
Worldwide Distribution - USA including UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY,HI, NC, and Internationally to CA, BE, IN, KW, and AU.
Reported risk: ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.
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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