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).
FDA Recall Z-0638-2010 · Posted 2010-01-22
Advertisement
Recalling FirmExelint International Co.
Recall StatusTerminated
Product CodeFMI
Date Initiated2009-12-23
Date Terminated2011-06-06
Product Quantity849,000
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
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.
Advertisement