The following brand name labeled products are under recall (all catalog numbers and all lot numbers under recall): NIPRO SafeTouch Safety Fistula Needle, Baxter Safety AV Fistula Set and EXEL Secure Touch Safety AV Fistula Needle Set.
FDA Recall Z-0408-03 · Posted 2003-05-21
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Recalling FirmNipro Corp
Recall StatusTerminated
Product CodeFIE
Date Initiated2002-11-08
Date Terminated2008-04-15
Product Quantity6,984,000
Reason for Recall
Air or fluid leakage at the hub/needle junction.
Firm Action
The recall letters were mailed on November 8, 2002 to direct accounts and requested subrecall down to the health professional/clinic level. It was requested that Nipro be notified of all held and recovered product for pickup. Also new replacement product will be made available in the near future.
Root Cause
Other
Distribution Pattern
Nationwide and Canada
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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