Amplatz Goose Neck Microsnare Kit, Model SK400 (175 cm length x 4mm loop snare x .018'',0.46mm) and SK701 (200 cm length x 7mm loop snare x 0.18'' x 0.46mm) ev3, 4600 Nathan Lane North, Plymouth, Minnesota, 55442-2920 USA. For one time use only. Sterilization with Ethylene Oxide gas. Do not resterilize.------The Amplatz Goose Neck Microsnare Kit contains one Amplatz Goose Neck Microsnare, one Microcatheter, one Microsnare Introducer and one torque device.
FDA Recall Z-0894-06 · Posted 2006-06-02
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Recalling FirmEv3, Inc
Recall StatusTerminated
Product CodeDXE
Date Initiated2005-08-16
Date Terminated2006-12-26
Product Quantity58
Reason for Recall
ev3 has determined that one test unit from each of two lots did not meet mininum tensile strength requirements and therefore the entire lots are being recalled.
Firm Action
The recall was initiated on August 16, 2005. All units distributed have been accounted for and the firm completed the recall on December 29, 2005. The firm sent a notification to customers with a Device Recall Field Action Form to record if devices remain at the sight and include with devices returned for credit or replacement.
Root Cause
Other
Distribution Pattern
AL, AR, CA, CO, FL, IL, KS, MA, MO, NY, PA, TX, WA, VA, Canada, Germany, Japan
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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