Recall Z-0639-2010 ยท FPA Set, Administration, Intravascular
Exelint International Co.
Exel Safety Huber Infusion Sets (20G and 22G sizes with Catalog Numbers 37854S, 37855S. 37858S).
| Date | Jan 22, 2010 (initiated Dec 23, 2009) |
| Status | Terminated |
| Reason | 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 |
| 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081210 | NIPRO SAFETOUCH HUBER INFUSTION SET Nipro Medical Corp., Oct 21, 2008 |