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U.S. Department of Health and Human Services

Class 2 Device Recall Adult 02 Transducer

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  Class 2 Device Recall Adult 02 Transducer see related information
Date Initiated by Firm March 11, 2008
Date Posted September 19, 2008
Recall Status1 Terminated 3 on June 29, 2012
Recall Number Z-1664-2008
Recall Event ID 47343
510(K)Number K012344  
Product Classification Pulse Oximeter - Product Code NLF
Product Adult 02 Transducer (Nellcor) - Reprocessed Sterile device -- Pulse Oximeter.
Code Information Catalog No. MAX-A Lot No. 118668, 140345, 144466, 148710, 149790, and 149925.
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 4416 of 4416
Distribution Class II Recall - Nationwide Distribution.
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = NLF and Original Applicant = VANGUARD MEDICAL CONCEPTS, INC.
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