Recall Z-0638-2010 ยท FMI Needle, Hypodermic, Single Lumen
Exelint International Co.
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).
| Date | Jan 22, 2010 (initiated Dec 23, 2009) |
| Status | Terminated |
| Reason | 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 |
| Root cause | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K895769 | EXEL HUBER NEEDLE Exel Intl., Feb 16, 1990 |