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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 1 Recall
Huber Infusion Set		see related information
Date Posted January 22, 2010
Recall Number Z-0639-2010
Product Exel Safety Huber Infusion Sets (20G and 22G sizes with Catalog Numbers 37854S, 37855S. 37858S).
Code Information Catalog 37854S Lot 09G31; Catalog 37855S Lot 09G31, Catalog 37858S Lot 09G31.
Recalling Firm/
Manufacturer		 Exelint International Co.
P. O. Box 3194
Culver City, California 90231-3194
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
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: info@exelint.com.
Quantity in Commerce 3,360
Distribution 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.
 
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