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Terminated

DeVilbiss iFill Personal Oxygen Station model number 535D.

FDA Recall Z-0038-2007 · Posted 2006-10-17

Recalling FirmSunrise Medical
Recall StatusTerminated
Product CodeCAW
Date Initiated2006-08-24
Date Terminated2009-08-27
Product Quantity252 units

Reason for Recall

Potential for oxygen cylinders to not fill completely

Firm Action

The recalling firm began to notify customers via telephone beginning on 8/24/06. An 'Urgent Medical Device Recall' letter was sent on 8/28/06. Customers were advised what model and serial numbers were affected and how to contact the firm and/or dealer to have the unit replaced. A customer service help line has been established (1-800-333-4000) to provide additional information for returning units.

Root Cause

Other

Distribution Pattern

The product was distriubted to 252 end users nationwide through 36 dealers.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K053240DEVILBISS OXYGEN CYLINDER FILLING SYSTEM, 535 SERIESSunrise Medical · 2006-02-03

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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