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Terminated

Reusable Ohmeda Compatible Finger Clip Sensor, Model Number: E403-02, Product Code: PS2225. To monitor oxygen saturation level of patients under doctor's care. Kentec Medical Inc., Irvine, CA 92614

FDA Recall Z-1188-2008 · Posted 2008-06-26

Recalling FirmKentec Medical Inc
Recall StatusTerminated
Product CodeDQA
Date Initiated2007-05-18
Date Terminated2012-02-29
Product Quantity41

Reason for Recall

Incompatible components: The Finger Clip Sensors - with a Serial Number prefix of PA514, PA515, YE508, ZC502 and ZG512 - are missing an additional diode and higher resistor in its existing configuration making them inoperable when used to interface with those Ohmeda Tuffsat monitors previously re-configured by Ohmeda to include a detection circuit for diodes.

Firm Action

Consignees were notified via telephone on 5/18/07 and an "Important Voluntary Market Withdrawal Notice" letter on 5/23/07. The letter instructed consignees to segregate and return all affected devices. The letter included an "Acknowledgement of Market Withdrawal Notification" form for customer to complete and return to the recalling firm. For additional information, contact 1-800-825-5996.

Root Cause

Process change control

Distribution Pattern

Nationwide Distribution including states of AZ, CA, CO, FL, KY, LA, MA, NC, NJ, TX and UT.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K970098E100 SERIES SPO2 SENSORSEpic Medical Equipment Services, Inc. · 1998-04-30

Official Source

View FDA Recall →

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

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