Adult 02 Transducer (Nellcor) - Reprocessed Sterile device -- Pulse Oximeter.
FDA device recall Z-1664-2008 · posted 2008-09-19 · Terminated
Recall details
- Recalling firm
- Ascent Healthcare Solutions, Inc.
- Reason for recall
- Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products.
- Action taken
- A recall notification letter titled Voluntary Medical Device Recall was sent to each consignee. If you have questions about this recall on numerous reprocessed devices, contact Moira Barton-Varty at 888-888-3433, ext. 5350 or at mbarton@ascenths.com.
- Root cause
- Process control
- Status
- Terminated
- Product code
- NLF
- Quantity affected
- 4416 of 4416
- Distribution
- Class II Recall - Nationwide Distribution.
- Date initiated
- 2008-03-11
- Date posted
- 2008-09-19
- Date terminated
- 2012-06-29
- Location
- Lakeland, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VANGUARD REPROCESSED PULSE OXIMETER SENSORS (K012344) | Vanguard Medical Concepts, Inc. | 2002-10-04 |