ComfortGel Nasal Mask size medium
FDA device recall Z-0179-04 · posted 2003-12-10 · Terminated
Recall details
- Recalling firm
- Respironics, Inc.
- Reason for recall
- product does not contain built in exhalation port
- Action taken
- The recalling firm telephoned the direct accounts to inform them of the problem and the need to return the product.
- Root cause
- Other
- Status
- Terminated
- Product code
- BZD
- Quantity affected
- 5293 units
- Distribution
- The products were shipped to sleep centers nationwide and in Canada.
- Date initiated
- 2003-09-29
- Date posted
- 2003-12-10
- Date terminated
- 2004-03-01
- Location
- Murrysville, PA
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