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Terminated

Western Medica OPC Portable Oxygen Conserving Regulator, Model MDL-7609, 1/2 - 5 LPM, packaged under the Medline label.

FDA Recall Z-0056-04 · Posted 2003-10-24

Recalling FirmWestern a Scott Fetzer Co
Recall StatusTerminated
Product CodeBZD
Date Initiated2003-10-02
Date Terminated2006-01-06
Product Quantity1,106 units

Reason for Recall

The demand valve is defective and does not function as intended in the 'Conservative Mode'.

Firm Action

The firm notified the affected consignees by letter on 10/2/2003. Customers were asked to return the units for replacements.

Root Cause

Other

Distribution Pattern

The device was distributed nationwide and into China and Japan.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K010747OPC OXYGEN CONSERVING REGULATOR, MODEL AHG 1968, LIN-7005, MDL-7609, MEM-7612, OPC-830Western Ent. · 2001-05-16

Official Source

View FDA Recall →

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

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