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Terminated

''ComforTEC II Single Use pH Probe *** Latex Free *** Do Not Re-use''. Packaged individually.

FDA Recall Z-0466-03 · Posted 2003-01-23

Recalling FirmSandhill Scientific, Inc
Recall StatusTerminated
Product CodeFFT
Date Initiated2003-01-08
Date Terminated2003-04-16
Product Quantity6678 probes

Reason for Recall

Failure of the dry silver chloride reference, resulting in malfunction and a 'Lead Off' indication.

Firm Action

All consignees were notified by letter on 01/08/2003.

Root Cause

Other

Distribution Pattern

Nationwide. Foreign distribution to Argentina, Canada, Chile, China, Ireland, Italy, Jordan, Malaysia, Netherlands, Spain.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K931963SANDHILL DISPOSABLE INTERNAL REFERENCE PH PROBESandhill Scientific, Inc. · 1994-09-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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