| Class 2 Device Recall Smiths Medical Medfusion infusion pump |  |
Date Initiated by Firm | November 16, 2009 |
Date Posted | January 15, 2010 |
Recall Status1 |
Terminated 3 on December 18, 2011 |
Recall Number | Z-0651-2010 |
Recall Event ID |
53940 |
510(K)Number | K040899 |
Product Classification |
Infusion pump - Product Code FRN
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Product | Smiths Medical Medfusion model 3010a syringe Infusion pump. REF 3010A. Rx Only. Smiths Medical MD, Inc., St. Paul, Minnesota 55112 (USA) |
Code Information |
serial number: M66331, M66332, M66333, M66334, M66335, M66336, M66337, M66339, M66340, M66341, M66342, M66343, M66344, M66345, M66721, M66722, M66723, M66724, M66725, M66726, M66727, M66728, M66729, M66730, M66731, M66732, M66733, M66734. |
Recalling Firm/ Manufacturer |
Smiths Medical ASD, Inc. 1265 Grey Fox Rd Saint Paul MN 55112-6929
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For Additional Information Contact | 651-628-7280 |
Manufacturer Reason for Recall | Smiths Medical has become aware of an increased trend in reports of Motor Not Running (MNR) and Motor Rate Error (MRE) alarm message events with certain Medfusion Syringe Infusion Pumps, Models 3010A and 3500 (Pump). MNR/ MRE are high priority alarm messages which can occur for a variety of reasons as part of the usual self-test functionality of the Pump. The Pump is designed so that when its so |
FDA Determined Cause 2 | Device Design |
Action | An Urgent Medical Device Recall letter, dated November 16, 2009, was sent to customers beginning November 16, 2009. The letter described the issue, identified affected devices, and asked that affected devices be returned to Smiths Medical to be inspected, repaired, if necessary, and returned back to medical facility. A Confirmation Form is also asked to be completed and returned to Smiths Medical.
To return Pumps or for questions regarding this Urgent Recall Notice, please contact Smiths Medical Customer Service Department at 1~866-270-7060.
Please report any issues with these Pumps please contact Smiths Medical Technical Customer Service Department at 1866-216-8806. |
Quantity in Commerce | 43 |
Distribution | AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY,OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV,
including Guam, Puerto Rico. OUS to include: Canada, Chile, Czech Republic,, England, France, Germany, Hong Kong, Ireland, Israel, Lebanon, Malaysia, Poland, Saudi Arabia, Scotland, Singapore, Sweden, Switzerland, United Arab Emirates. |
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 = FRN
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