FDA Medical Device Recalls (openFDA)
Exelint International Co.: Exel Safety Huber Infusion Sets (20G and 22G sizes with Catalog Numbers 37854S, 37855S. 37858S).
- Recall number
- Z-0639-2010
- Recalling firm
- Exelint International Co.
- Product
- Exel Safety Huber Infusion Sets (20G and 22G sizes with Catalog Numbers 37854S, 37855S. 37858S).
- Status
- Terminated
- Initiated
- 2009-12-23
- Posted
- 2010-01-22
- Terminated
- 2011-06-06
- 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.
- Lot, serial or model codes
- Catalog 37854S Lot 09G31; Catalog 37855S Lot 09G31, Catalog 37858S Lot 09G31.
- 510(k) numbers
- ["K081210"]
- PMA numbers
- not on file
- Product code
- FPA
- Firm FEI
- 1035907
- Firm city
- Culver City
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28