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Terminated

ComforTEC Plus Impedance Probe, a part of the Insight S980000 Gastrointestinal motility system

FDA Recall Z-0104-04 · Posted 2003-11-11

Recalling FirmSandhill Scientific, Inc
Recall StatusTerminated
Product CodeFFT
Date Initiated2003-09-24
Date Terminated2003-11-17
Product Quantity17 probes

Reason for Recall

Pouch containing pediatric probes was labeled as containing adult probes.

Firm Action

The 3 consignees were notified by telephone on 09/24/2003, followed by a letter.

Root Cause

Other

Distribution Pattern

CO, MT, TX.

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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