FDA Medical Device Recalls (openFDA)
Nipro Corp: The following brand name labeled products are under recall (all catalog numbers and all lot numbers under recall): NIPRO SafeTouch Safety Fistula Needle, Baxter Safety AV Fistula Set and EXEL Secure Touch Safety AV Fistula Needle Set.
- Recall number
- Z-0408-03
- Recalling firm
- Nipro Corp
- Product
- The following brand name labeled products are under recall (all catalog numbers and all lot numbers under recall): NIPRO SafeTouch Safety Fistula Needle, Baxter Safety AV Fistula Set and EXEL Secure Touch Safety AV Fistula Needle Set.
- Status
- Terminated
- Initiated
- 2002-11-08
- Posted
- 2003-05-21
- Terminated
- 2008-04-15
- Reason
- Air or fluid leakage at the hub/needle junction.
- Root cause
- Other
- Action
- The recall letters were mailed on November 8, 2002 to direct accounts and requested subrecall down to the health professional/clinic level. It was requested that Nipro be notified of all held and recovered product for pickup. Also new replacement product will be made available in the near future.
- Quantity
- 6,984,000
- Distribution
- Nationwide and Canada
- Lot, serial or model codes
- All lot numbers in current distribution are under recall.
- 510(k) numbers
- ["K002813"]
- PMA numbers
- not on file
- Product code
- FIE
- Firm FEI
- 1000132332
- Firm city
- Miami
- Firm state
- FL
- 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