Western Medica OPC Portable Oxygen Conserving Regulator, Model LIN-7005, 1/2 - 5 LPM, packaged under the Lincare label.
FDA device recall Z-0055-04 · posted 2003-10-24 · Terminated
Recall details
- Recalling firm
- Western a Scott Fetzer Co
- Reason for recall
- The demand valve is defective and does not function as intended in the 'Conservative Mode'.
- Action taken
- The firm notified the affected consignees by letter on 10/2/2003. Customers were asked to return the units for replacements.
- Root cause
- Other
- Status
- Terminated
- Product code
- BZD
- Quantity affected
- 1,537 units
- Distribution
- The device was distributed nationwide and into China and Japan.
- Date initiated
- 2003-10-02
- Date posted
- 2003-10-24
- Date terminated
- 2006-01-06
- Location
- Westlake, OH
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OPC OXYGEN CONSERVING REGULATOR, MODEL AHG 1968, LIN-7005, MDL-7609, MEM-7612, OPC-830 (K010747) | Western Ent. | 2001-05-16 |