Reusable Ohmeda Compatible Finger Clip Sensor, Model Number: E403-02, Product Code: PS2225. To monitor oxygen saturation
FDA device recall Z-1188-2008 · posted 2008-06-26 · Terminated
Recall details
- Recalling firm
- Kentec Medical Inc
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- DQA
- Quantity affected
- 41
- Distribution
- Nationwide Distribution including states of AZ, CA, CO, FL, KY, LA, MA, NC, NJ, TX and UT.
- Date initiated
- 2007-05-18
- Date posted
- 2008-06-26
- Date terminated
- 2012-02-29
- Location
- Irvine, CA
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Related 510(k) clearances
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| E100 SERIES SPO2 SENSORS (K970098) | Epic Medical Equipment Services, Inc. | 1998-04-30 |