FDA Medical Device Recalls (openFDA)
Kentec Medical Inc: 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
- Recall number
- Z-1188-2008
- Recalling firm
- Kentec Medical Inc
- Product
- 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
- Status
- Terminated
- Initiated
- 2007-05-18
- Posted
- 2008-06-26
- Terminated
- 2012-02-29
- Reason
- 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.
- Root cause
- Process change control
- 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.
- Quantity
- 41
- Distribution
- Nationwide Distribution including states of AZ, CA, CO, FL, KY, LA, MA, NC, NJ, TX and UT.
- Lot, serial or model codes
- Serial Numbers: YE508/001, YE508/002, YE508/003, YE508/004, YE508/005, YE508/006, YE508/007, YE508/008, YE508/009, YE508/010; ZC502/001, ZC502/002, ZC502/003, ZC502/004, ZC502/005, ZC502/006; ZG512/001, ZG512/002, ZG512/003, ZG512/004, ZG512/005, ZG512/006, ZG512/007, ZG512/008, ZG512/009, ZG512/010, ZG512/011, ZG512/012, ZG512/013, ZG512/014, ZG512/015; PA514/001, PA514/002, PA514/003, PA514/004, PA514/005, PA514/006, PA514/006, PA514/007, PA514/008, PA514/009, PA514/010; PA515/001, PA515/002, PA515/003, PA515/004, PA515/005, PA515/006, PA515/007, PA515/008, PA515/009, PA515/010, PA515/011, PA515/012, PA515/013, PA515/014, PA515/015, PA515/016, PA515/017, PA515/018, PA515/019, PA515/020, PA515/021, PA515/022, PA515/023, PA515/024, PA515/025, PA515/026, PA515/027, PA515/028, PA515/029, PA515/030, PA515/031, PA515/032, PA515/033, PA515/034 and PA515/035
- 510(k) numbers
- ["K970098"]
- PMA numbers
- not on file
- Product code
- DQA
- Firm FEI
- 2080225
- Firm city
- Irvine
- Firm state
- CA
- 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