Exel Safety Huber Infusion Sets (20G and 22G sizes with Catalog Numbers 37854S, 37855S. 37858S).
FDA Recall Z-0639-2010 · Posted 2010-01-22
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Recalling FirmExelint International Co.
Recall StatusTerminated
Product CodeFPA
Date Initiated2009-12-23
Date Terminated2011-06-06
Product Quantity3,360
Reason for Recall
Coring of port's septum, which may lead to: Decreased effectiveness of port, infection, necrosis, swelling, and embolization, which may result in Pulmonary Embolism, Limb ischemia, stroke, local extravasation of medication such as chemotherapy or other caustic material, may lead to local tissue necrosis, granulomas, failure to deliver therapy, need for additional surgery to replace implanted port
Firm Action
Distributors have been advised to cease distribution of any recalled needles and infusion sets; to quarantine any remaining; to document amount on Customer Response Form; to return form to Exel (firm); to arrange for return of product to Exel for credit. Distributors also are advised to share recall notice with all affected customers. Contact phone: 727-827-1922x0 (M-F 9a-5p EST). Contact email: [email protected]
Root Cause
Device Design
Distribution Pattern
US (VA TX NV KY OH NH MS NY OH NM DE WA AZ IL PA OR CO FL GA LA UT MI WI NV CA NJ MO IA) 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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