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U.S. Department of Health and Human Services

Class 1 Device Recall Huber Infusion Set

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 Class 1 Recall
Huber Infusion Set
see related information
Date Posted January 22, 2010
Recall Status1 Terminated on June 06, 2011
Recall Number Z-0639-2010
Recall Event ID 54203
Premarket Notification
510(K) Number
K081210 
Product Classification Set, Administration, Intravascular - Product Code FPA
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
Manufacturer 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
FDA Determined
Cause 2
DESIGN: Device Design
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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FPA and Original Applicant = NIPRO MEDICAL CORP.
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