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FDA Medical Device Recalls (openFDA)

Chad Therapeutics Inc: Sequoia Oxymatic electronic oxygen conservers. Models OM-302, OM-311 ***and OM-312***.

Recall number
Z-1068-05
Recalling firm
Chad Therapeutics Inc
Product
Sequoia Oxymatic electronic oxygen conservers. Models OM-302, OM-311 ***and OM-312***.
Status
Terminated
Initiated
2005-03-25
Posted
2005-08-03
Terminated
2006-08-30
Reason
"Shot size" below manufacturing specifications. Risk of less than the specified quantity of oxygen delivered per pulse.
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
***244 units***
Distribution
Nationwide and to Canada, Sweden, Norway***
Lot, serial or model codes
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
510(k) numbers
["K000890","K003455"]
PMA numbers
not on file
Product code
BZD
Firm FEI
2024040
Firm city
Chatsworth
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

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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

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