Sequoia Oxymatic electronic oxygen conservers. Models OM-302, OM-311 ***and OM-312***.
FDA Recall Z-1068-05 · Posted 2005-08-03
Recalling FirmChad Therapeutics Inc
Recall StatusTerminated
Product CodeBZD
Date Initiated2005-03-25
Date Terminated2006-08-30
Product Quantity***244 units***
Reason for Recall
"Shot size" below manufacturing specifications. Risk of less than the specified quantity of oxygen delivered per pulse.
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide and to Canada, Sweden, Norway***
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.