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.
FDA Recall Z-1398-2010 · Posted 2010-04-15
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Recalling FirmMindray DS USA, Inc., dba Datascope Patient Monitoring
Recall StatusTerminated
Product CodeDQA
Date Initiated2009-12-31
Date Terminated2011-12-09
Product QuantityTotal: 33,976 boxes of 20 (boxes of 20 packaged into boxes of 200) in US, 801 boxes OUS
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.
Firm 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.
Root Cause
Process control
Distribution Pattern
Worldwide Distribution -- United States, Canada and Australia. Nationwide distribution to hospitals, medical facilities and distributors as well as to Canada and Australia.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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