ClearanceBrief
Recall Z-1068-05 ยท BZD Ventilator, Non-Continuous (Respirator)

Chad Therapeutics Inc

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

DateAug 3, 2005 (initiated Mar 25, 2005)
StatusTerminated
Reason"Shot size" below manufacturing specifications. Risk of less than the specified quantity of oxygen delivered per pulse.
Root causeOther
ActionFirm 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***
DistributionNationwide and to Canada, Sweden, Norway***
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K000890CHAD THERAPEUTICS OXYMATIC MODEL 401
Chad Therapeutics, Inc., Jun 16, 2000
K003455MODIFICATION TO CHAD THERAPEUTICS OXYMATIC MODEL 401
Chad Therapeutics, Inc., Dec 6, 2000