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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-0640-2010
Recall Event ID 54203
Premarket Notification
510(K) Number
K895770 
Product Classification Set, Administration, Intravascular - Product Code FPA
Product Exel Huber Infusion Set (Catalog Numbers 26940R, 26941R, 26944R, 26945R, 26946R, 26948R, 26949R, 26950R, 27940R, 27941R, 27944R, 27945R, 27946R, 27948R, 27949R, 27950R, 26954R, 26955R, 26958R, 26959R, 27954R, 27955R, 27958R, 27959R).
Code Information Catalog 27959R Lots: 07F25 08B04 08C29 08E23 08K26 09A10; Catalog 27959R Lots: 07A19 07D25 09G21; Catalog 27955R Lots: 07F18 07H23 07K26 08G14 08D10 08E22 08H05 08H23 09G21; Catalog 27954R Lots: 08E09 08E21 08J22 09B23 09C28; Catalog 27949R Lots: 07C20 07F26 07H03 07I 20 07I21 07K22 08B26 08E12 08G17 08K25 08L19 09D03 09F16 09G22 09H12; Catalog 27948R Lots: 07I13 07J09 08G08 08I09; Catalog 27950R Lots: 08D23 08E01 09D01; Catalog 27945R Lots: 07A09 07A25 07F19 07G10 07J23 07K13 07L03 08A26 08B01 08B25 08E02 08F16 08H05 08J06 08J21 08K28 08L10 08L17 08L25 09A17 09C23 09C24 09D01 09D29 09E29 09F09 09F17 09G23; Catalog 27944R Lots: 07A08 07B10 07B13 07B24 07F08 07F15 07G17 07H03 07H10 07J09 07L17 08A11 08C12 08C28 08D08 08F04 08H21 08I22 08K06 08K14 09A17 09A29 09B11 09B17 09D17 09G17; Catalog 27946R Lots: 07A18 07C30 08D11 09D29 09F16 09G24 09H17; Catalog 27941R Lots: 07I12 09B12 09C09 09F17 09H17; Catalog 27940R Lots: 07I11 07L17 08I12 09D17.
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 1,158,000
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 = EXEL INTL.
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