Recall Z-1396-2010 ยท DXN System, Measurement, Blood-Pressure, Non-Invasive
Mindray DS USA, Inc., dba Datascope Patient Monitoring
SmarTemp Probe Covers with the Accutorr V 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.
| Date | Apr 15, 2010 (initiated Dec 31, 2009) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091068 | ACCUTORR V MONITOR, MODEL 0998-00-2000 Datascope Corp., Patient Monitoring Division, May 8, 2009 |