Oximetry Ear Clip Sensor model number 948. Filter, mask, and/or accessories for sleep therapy and ventilation devices, R
FDA device recall Z-1092-2008 · posted 2008-04-24 · Terminated
Recall details
- Recalling firm
- Respironics, Inc.
- Reason for recall
- Foreign material: Glass fragments may present in the plastic bag material used to ship components.
- Action taken
- The recalling firm issued a Recall Notification dated 10/18/07 to its customers. Replacement products were to be sent.
- Root cause
- Environmental control
- Status
- Terminated
- Product code
- DOA
- Quantity affected
- 20950 units
- Distribution
- The products were shipped nationwide to medical facilities.
- Date initiated
- 2007-10-15
- Date posted
- 2008-04-24
- Date terminated
- 2009-09-01
- Location
- Murrysville, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODEL 2500, PALMSAT HAND HELD PULSE OXIMETER, MODEL 2500 (K002690) | Nonin Medical, Inc. | 2000-10-11 |