Exel Huber Needles (Right angle and Straight Models with Catalog Numbers: 26901CE, 26902CE, 26903CE, 26904CE, 26905CE, 2
FDA device recall Z-0638-2010 · posted 2010-01-22 · Terminated
Recall details
- Recalling firm
- Exelint International Co.
- 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
- 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
- FMI
- Quantity affected
- 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.
- 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 NEEDLE (K895769) | Exel Intl. | 1990-02-16 |