Exel Huber Infusion Set (Catalog Numbers 26940R, 26941R, 26944R, 26945R, 26946R, 26948R, 26949R, 26950R, 27940R, 27941R,
FDA device recall Z-0640-2010 · posted 2010-01-22 · Terminated
Recall details
- Recalling firm
- Exelint International Co.
- 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
- Action taken
- 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
- Root cause
- Device Design
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 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.
- Date initiated
- 2009-12-23
- Date posted
- 2010-01-22
- Date terminated
- 2011-06-06
- Location
- Culver City, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EXEL HUBER INFUSION SET (K895770) | Exel Intl. | 1990-07-19 |