Smiths Medical Medfusion model 3010a syringe Infusion pump. REF 3010A. Rx Only. Smiths Medical MD, Inc., St. Paul, Minne

FDA device recall Z-0651-2010 · posted 2010-01-15 · Terminated

Recall details

Recalling firm

Smiths Medical ASD, Inc.

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

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

FRN

Quantity affected

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, P

Date initiated

2009-11-16

Date posted

2010-01-15

Date terminated

2011-12-18

Location

Saint Paul, MN

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