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U.S. Department of Health and Human Services

Class 2 Device Recall SmarTemp Probe Covers

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  Class 2 Device Recall SmarTemp Probe Covers see related information
Date Initiated by Firm December 31, 2009
Date Posted April 15, 2010
Recall Status1 Terminated 3 on December 09, 2011
Recall Number Z-1398-2010
Recall Event ID 54175
510(K)Number K072235  
Product Classification Oximeter - Product Code DQA
Product SmarTemp Probe Covers for use with the VS-800 Monitor; Rx only, Mindray DS USA, Inc. Mahway, NJ 07430. Packaged in boxes of 20, Model ST010, also distributed in boxes of 2000 (10 individual boxes of 200); SmarTemp Module Kit (contains one box of 20 probes) and SmarTemp Temperature Probe Kits (contains one box of 20 probes).

Probe Cover for use with the SmarTemp Reusable Temperature Probe.
Code Information All lots of the following product numbers: 1. M09A-20-62124 Covers, Temp Probe- box of 20 probes and M09A-30-62128 Covers, Temp Probe - box of 2000 (10 boxes of 200)  2. A box of 20 Disposable Probe Covers (part number M09A-20-62124) are also included in the following kits:  0020-00-0192 - SmarTemp Module Kit and 6006-30-39590 - SmarTemp Temperature Probe Kit.
Recalling Firm/
Manufacturer		 Mindray DS USA, Inc., dba Datascope Patient Monitoring
800 Macarthur Blvd
Mahwah NJ 07430
For Additional Information Contact Diana Arpino
201-995-8391
Manufacturer Reason
for Recall		 SmarTemp Disposable Probe covers may contain microscopic holes in the molded seam that would allow liquids or body fluids inside the cover and potentially contaminate the temperature probe.
FDA Determined
Cause 2		 Process control
Action Mindray DS USA, Inc. issued an "Urgent Product Recall" notification dated December 31, 2009 by certified mail. Consignees were informed of the affected product and requested to discard all remaining stock. Replacement product will be provided by the firm at no cost. For further information, contact Mindray DS USA, Inc. at 1-201-995-8000.
Quantity in Commerce Total: 33,976 boxes of 20 (boxes of 20 packaged into boxes of 200) in US, 801 boxes OUS
Distribution Worldwide Distribution -- United States, Canada and Australia. Nationwide distribution to hospitals, medical facilities and distributors as well as to Canada and Australia.
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 = DQA and Original Applicant = SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
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