Z-1188-2008

Reusable Ohmeda Compatible Finger Clip Sensor, Model Number: E403-02

Name: Z-1188-2008 Reusable Ohmeda Compatible Finger Clip Sensor, Model Number: E403-02
Creator: Kentec Medical Inc
Published: 2007-05-18
License: https://open.fda.gov/license/

Kentec Medical, LLC / initiated 2007-05-18 / Terminated

FDA source

Kentec Medical Inc began a recall of Reusable Ohmeda Compatible Finger Clip Sensor, Model Number: E403-02, Product Code: PS2225. To monitor oxygen saturation level of patients under doctor's care... on 2007-05-18. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1188-2008
Status: Terminated
Initiated: 2007-05-18
Posted: 2008-06-26
Terminated: 2012-02-29
Recalling firm: Kentec Medical, LLC
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
Product code: DQA Oximeter
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.
FDA 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 in commerce: 41
Distribution: Nationwide Distribution including states of AZ, CA, CO, FL, KY, LA, MA, NC, NJ, TX and UT.
Product codes and lots: 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

Product code DQA

K970098Class IIE100 Series Spo2 SensorsEpic Medical Equipment Services, Inc. / cleared 1998-04-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)