Recall Z-1663-2008
Ascent Healthcare Solutions, Inc. · initiated March 11, 2008
Product
Neonatal/Adult 02 Transducer, (Nellcor), Latex Free. - Reprocessed Sterile device -- Pulse Oximeter.
Codes / lots: Catalog No. MAX-N, Lot No. 118141, 139207, and 135902.
Reason for recall
Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products.
FDA-determined cause: Process control
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.
Details
- Recall number
- Z-1663-2008
- Initiated
- March 11, 2008
- Posted by FDA
- September 19, 2008
- Terminated
- June 29, 2012
- Product code
- NLF – Oximeter, Reprocessed
- Quantity
- 1752 of 1752 (data indicates 1776 dist - some devices were returned and redistributed)
- Distribution
- Class II Recall - Nationwide Distribution.
- Recalling firm
- Ascent Healthcare Solutions, Inc., Lakeland, FL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1661-2008 | Kendall Calf Garment - Reprocessed Sterile device used to cover calf while conducting…Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety… | 03/11/2008Terminated |
| Z-1662-2008 | Zimmer, 34" Tourniquet Cuff Single Port Single Bladder Luer Lock Connector Brown Trim…Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety… | 03/11/2008Terminated |
| Z-1664-2008 | Adult 02 Transducer (Nellcor) - Reprocessed Sterile device -- Pulse Oximeter.Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety… | 03/11/2008Terminated |
| Z-1665-2008 | Hill-Rom Foot Garment - Reprocessed Sterile device -- Compressible limb sleeve.Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety… | 03/11/2008Terminated |
| Z-1666-2008 | Huntleigh Healthcare, Calf Garment - Regular. -- Reprocessed Sterile device --…Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety… | 03/11/2008Terminated |
| Z-1667-2008 | Mitek 3.5 mm Side Effect Electrode - - Reprocessed Sterile device -- Orthopedic…Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety… | 03/11/2008Terminated |
| Z-1668-2008 | Arthrocare 3.6 mm Right Angle - Reprocessed Sterile device -- Orthopedic Arthroscope.Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety… | 03/11/2008Terminated |
| Z-1669-2008 | Turbovac Suction Wand - Reprocessed Sterile device -- Orthopedic Arthroscope.Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety… | 03/11/2008Terminated |
| Z-1670-2008 | Mitek Angled Side Effect Electrode - Reprocessed Sterile device -- Orthopedic Arthroscope.Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety… | 03/11/2008Terminated |
| Z-1671-2008 | Huntleigh Healthcare Thigh Garment. - Reprocessed Sterile device -- Compressible limb…Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety… | 03/11/2008Terminated |
| Z-1672-2008 | VasoPress Foot Garment. - Reprocessed Sterile device -- Compressible limb sleeve.Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety… | 03/11/2008Terminated |
| Z-1673-2008 | Tourniquet Cuff Single Port Single Bladder - Reprocessed Sterile device -- Pneumatic…Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety… | 03/11/2008Terminated |
| Z-1674-2008 | Inlet Medical Suture Passer - Reprocessed Sterile device -- Endoscope and accessories.Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety… | 03/11/2008Terminated |
| Z-1675-2008 | Biomet Stablecut Saw Blade - Reprocessed Sterile device -- Powered Saw and Accessories.Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety… | 03/11/2008Terminated |
| Z-1676-2008 | Kendall Thigh Garment - Reprocessed Sterile device -- Compressible limb sleeve.Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety… | 03/11/2008Terminated |
| Z-1677-2008 | Stryker Oscillating & Sagittal Blade - Reprocessed Sterile device -- Powered Saw and…Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety… | 03/11/2008Terminated |
| Z-1678-2008 | Color Cuff II, Double Port Single Bladder - Reprocessed Sterile device -- Pneumatic…Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety… | 03/11/2008Terminated |
| Z-1679-2008 | Zimmer Tourniquet Cuff - Reprocessed Sterile device -- Pneumatic tourniquet.Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety… | 03/11/2008Terminated |
| Z-1680-2008 | Turbovac Suction Wand - Reprocessed Sterile device -- Orthopedic Arthroscope.Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety… | 03/11/2008Terminated |
| Z-1681-2008 | Mitek Angled Side Effect Electrode - Reprocessed Sterile device -- Orthopedic Arthroscope.Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety… | 03/11/2008Terminated |
| Z-1682-2008 | Stryker Oscillating & Sagittal Blade - Reprocessed Sterile device -- Powered Saw and…Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety… | 03/11/2008Terminated |
| Z-1683-2008 | Infant 02 Transducer (Nellcor) - Reprocessed Sterile device -- Pulse Oximeter.Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety… | 03/11/2008Terminated |