FDA Medical Device Recalls (openFDA)
Ascent Healthcare Solutions, Inc.: Neonatal/Adult 02 Transducer, (Nellcor), Latex Free. - Reprocessed Sterile device -- Pulse Oximeter.
- Recall number
- Z-1663-2008
- Recalling firm
- Ascent Healthcare Solutions, Inc.
- Product
- Neonatal/Adult 02 Transducer, (Nellcor), Latex Free. - Reprocessed Sterile device -- Pulse Oximeter.
- Status
- Terminated
- Initiated
- 2008-03-11
- Posted
- 2008-09-19
- Terminated
- 2012-06-29
- 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.
- Lot, serial or model codes
- Catalog No. MAX-N, Lot No. 118141, 139207, and 135902.
- 510(k) numbers
- ["K012344"]
- PMA numbers
- not on file
- Product code
- NLF
- Firm FEI
- 1000132435
- Firm city
- Lakeland
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28