Recall Z-1663-2008 ยท NLF Oximeter, Reprocessed
Ascent Healthcare Solutions, Inc.
Neonatal/Adult 02 Transducer, (Nellcor), Latex Free. - Reprocessed Sterile device -- Pulse Oximeter.
| Date | Sep 19, 2008 (initiated Mar 11, 2008) |
| Status | Terminated |
| Reason | Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 1752 of 1752 (data indicates 1776 dist - some devices were returned and redistributed) |
| Distribution | Class II Recall - Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012344 | VANGUARD REPROCESSED PULSE OXIMETER SENSORS Vanguard Medical Concepts, Inc., Oct 4, 2002 |