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U.S. Department of Health and Human Services

Class 1 Device Recall Exel Huber Needle

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 Class 1 Recall
Exel Huber Needle
see related information
Date Posted January 22, 2010
Recall Status1 Terminated on June 06, 2011
Recall Number Z-0638-2010
Recall Event ID 54203
Premarket Notification
510(K) Numbers
K081210  K895769  K895770 
Product Classification Needle, Hypodermic, Single Lumen - Product Code FMI
Product Exel Huber Needles (Right angle and Straight Models with Catalog Numbers: 26901CE, 26902CE, 26903CE, 26904CE, 26905CE, 26906CE, 26907CE, 26908CE, 26909CE, 26910CE, 26911CE, 26921CE, 26922CE, 26923CE, 26924CE, 26925CE, 26926CE, 26927CE, 26928CE, and 26929CE).
Code Information Catalog 26921CE Lots: 08D25 08F23 08H27; Catalog 26922; Lots: 07C20 07E22 07E26 07F05 07G03 07H06 07I03 07K12 07L14 08A18 08C10 08F09 08F25 08G01 08G14 08H18 08I17 08J02 08J22 08K19 08K27 08L01 09A13 09A27 09B23 09C30 09D27 09E01 09F05 09F19 09G16 09G29; Catalog 26942CE Lots: 08B09 08B23 08E26 09F22 09G15; Catalog 26925CE Lots: 09F09; Catalog 26923CE Lots: 07H09 07I17 07J16 07K16 08D01 08E12 08F11 08G02 08H02 08H21 08I02 08I23 08J06 08K04 08L03 09A17 09A23 09B02 09C10 09D01 09F10; Catalog 26902CE Lots: 08F18 08K24 09F05; Catalog 26904CE Lots: 07D24 07H02 07H11 08F13 08F20 09B10 09C06 09D13 09E15; Catalog 26906CE Lots: 08H11 09E16; Catalog 26901CE Lots: 07L21 08D16 08H11 09A09 09C02 09D07 09E13 09F01 09GO7; Catalog 26906CE Lots: 07I22 07K21 08B18 08C17 08D21 08E15 09B12 09C05 09D10 09D27 09E27 09F26 09G09; Catalog 26909CE Lots: 07F08 07G25; Catalog 26907CE Lots: 07C27 07J13 08I19 09A07 09D29 09E12 09E26.
Recalling Firm/
Manufacturer
Exelint International Co.
P. O. Box 3194
Culver City, California 90231-3194
Manufacturer Reason
for Recall
Non-coring needles that, when inserted into an implanted port, were shown to core the silicone port's septum. Coring of port's septum 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
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 849,000
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 = FMI and Original Applicant = EXEL INTL.
510(K)s with Product Code = FMI and Original Applicant = NIPRO MEDICAL CORP.
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