DeVilbiss PD1000A Pulse Dose Oxygen Conserving Cylinder
FDA Recall Z-0731-2007 · Posted 2007-04-21
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Recalling FirmSunrise Medical
Recall StatusTerminated
Product CodeNFB
Date Initiated2007-01-24
Date Terminated2009-08-27
Product Quantity4,169 units (Z-0731/0732-2007)
Reason for Recall
Cylinder could lose oxygen at high pressure after the filling process
Firm Action
The recalling firm began to notify customer via telephone on 1/24/07. An ''Urgent Medical Device Recall Letter'' was sent on 1/29/07. Customers were advised what model and serial numbers were affected and how to contact the firm and/or dealer to have the unit replaced. The recalling firm identified additional serial numbers that were involved in the recall therefore another Urgent Medical Device Recall Letter dated 6/12/07 was sent to the customers that received the addiitonal units.
Root Cause
Other
Distribution Pattern
Worldwide-original shipments to distributors/dealers USA and Canada.
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.
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