Z-1068-05

Sequoia Oxymatic electronic oxygen conservers. Models OM-302, OM-311 and OM-312

Name: Z-1068-05 Sequoia Oxymatic electronic oxygen conservers. Models OM-302, OM-311 ***and OM-312***
Creator: Chad Therapeutics Inc
Published: 2005-03-25
License: https://open.fda.gov/license/

Chad Therapeutics, Inc. / initiated 2005-03-25 / Terminated / root cause: manufacturing process

FDA source

Chad Therapeutics Inc began a recall of Sequoia Oxymatic electronic oxygen conservers. Models OM-302, OM-311 ***and OM-312*** on 2005-03-25. The reason FDA records is ""Shot size" below manufacturing specifications. Risk of less than the specified quantity of oxygen delivered per pulse". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1068-05
Status: Terminated
Initiated: 2005-03-25
Posted: 2005-08-03
Terminated: 2006-08-30
Recalling firm: Chad Therapeutics, Inc.
Product: Sequoia Oxymatic electronic oxygen conservers. Models OM-302, OM-311 ***and OM-312***.
Product code: BZD Ventilator, Non-Continuous (Respirator)
Reason for recall: "Shot size" below manufacturing specifications. Risk of less than the specified quantity of oxygen delivered per pulse.
Root cause tag: manufacturing process
FDA root cause: Other
Action: Firm recalled via email and letter on 3/25/2005. Firm is requesting returns of all units. Recall is on-going and is to the user or patient level.
Quantity in commerce: ***244 units***
Distribution: Nationwide and to Canada, Sweden, Norway***
Product codes and lots: For model #OM-302: Serial #21404202668-21404202680, 21404202682-21404202706, 21404202708-21404202709, 21404202711, 21404202713-21404202715, 21404202722, 21404202725, 21404202728, 21404202730, 21404202733-21404202735, 21404202738-21404202739, 21404202758, 21404202761, 21404202763; For model #OM-311: Serial #21404105027, 21404105030, 2140410503041, 21404105030, 21404105054-21404105055-21404105061, 21404105063-21404105066, 21404105068-21404105070, 21404105073-21404105074, 21404105076, 21404105078-21404105083, 21404105085-21404105086, 21404105089-21404105091, 21404105093-21404105094, 21404105096, 21404105100-21404105102, 21404105105, 21404105107-21404105113, 21404105115-21404105116, 21404105119, 21404105123-21404105124, 21404105127-21404105128, 21404105130-21404105131, 21404105133, 21404105137-21404105139, 21404105142-21404105144, 21404105151-21404105152, 21404105157, 21404105161, 21404105164-21404105168, 21404105170, 21404105172, 21404105178, 21404105180, 21404105182, 21404105185, 21404105194, 21404105201, 21404105204, 21404105206, 21404105209, 21404105211-21404105213, 21404105218, 21404105270-21404105271, 21404105273-21404105274, 21404105276-21404105277, 21404105279; For model #OM-312: Serial #21404301082-21404301159, 21404301161-21404301178

Product code BZD

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)