Date Initiated by Firm | March 11, 2008 |
Date Posted | September 19, 2008 |
Recall Status1 |
Terminated 3 on June 29, 2012 |
Recall Number | Z-1663-2008 |
Recall Event ID |
47343 |
510(K)Number | K012344 |
Product Classification |
Pulse Oximeter - Product Code NLF
|
Product | Neonatal/Adult 02 Transducer, (Nellcor), Latex Free. - Reprocessed Sterile device -- Pulse Oximeter. |
Code Information |
Catalog No. MAX-N, Lot No. 118141, 139207, and 135902. |
Recalling Firm/ Manufacturer |
Ascent Healthcare Solutions, Inc. 5307 Great Oak Drive Lakeland FL 33815-3113
|
For Additional Information Contact | 800-887-2337 Ext. 203 |
Manufacturer Reason for Recall | Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products. |
FDA Determined Cause 2 | 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 in Commerce | 1752 of 1752 (data indicates 1776 dist - some devices were returned and redistributed) |
Distribution | Class II Recall - Nationwide Distribution. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = NLF
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