FDA Medical Device Recalls (openFDA)
Sandhill Scientific, Inc: ''ComforTEC II Single Use pH Probe *** Latex Free *** Do Not Re-use''. Packaged individually.
- Recall number
- Z-0466-03
- Recalling firm
- Sandhill Scientific, Inc
- Product
- ''ComforTEC II Single Use pH Probe *** Latex Free *** Do Not Re-use''. Packaged individually.
- Status
- Terminated
- Initiated
- 2003-01-08
- Posted
- 2003-01-23
- Terminated
- 2003-04-16
- Reason
- Failure of the dry silver chloride reference, resulting in malfunction and a 'Lead Off' indication.
- Root cause
- Other
- Action
- All consignees were notified by letter on 01/08/2003.
- Quantity
- 6678 probes
- Distribution
- Nationwide. Foreign distribution to Argentina, Canada, Chile, China, Ireland, Italy, Jordan, Malaysia, Netherlands, Spain.
- Lot, serial or model codes
- All product models: C2NS, C2NS-P, C2NS-A, C2N5, C2N10, C2N15, C2N10-V, C2IS, C2I5, C2I10, C2I15, C2I10-V. All lot numbers: U02314 through U021216N-15G.
- 510(k) numbers
- ["K931963"]
- PMA numbers
- not on file
- Product code
- FFT
- Firm FEI
- 2023374
- Firm city
- Highlands Ranch
- Firm state
- CO
- 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