Deltec 3000 Large Volume Infusion Pump, CE 0473, RX Only, Smiths Medical MD, Inc. 1265 Grey Fox Road, St. Paul, MN 55112

FDA device recall Z-1604-2008 · posted 2008-09-23 · Terminated

Recall details

Recalling firm

Smiths Medical MD, Inc.

Reason for recall

The Deltec, Graseby, and 3M, Large Volume Infusion Pump - Models 3000 and 3100, may deliver an unintended bolus if the pump door is opened and then immediately closed. This problem is due to a timing delay when the pumping mechanism resets itself.

Action taken

A Smiths Medical "Urgent Medical Device Correction" letter dated 2/5/08 was sent to consignees on 2/27/08. The letter was addressed to Risk/Safety Managers, Clinicians, Nursing Staff and other users of the above products. The letter also included Details on affected devices, Description of the problem , Advice on action to be taken by the user, Warning and requested the return the confirmation form. Contact Smiths Medical at 1-800-426-2448 for assistance. Please note: The 3M was the original brand for the large volume infusion pump models 3000 and 3100 marketed in the USA from 1994 through 1997. The Graseby large volume infusion pump models 3000 and 3100 were marketed from 1997 through 1999. Since 1999, the current marketed brand is the Deltec models 3000 and 3100. Smith Medical MD, Inc., included the 3M and Graseby brand large volume infusion pumps in the product field safety notice in the event these brands of infusion pumps are still in use.

Root cause

Process control

Status

Terminated

Product code

FRN

Quantity affected

2303 (total)

Distribution

AL, AR, AZ, CA, CO, CT, DC, FL. GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, ,MO, MS, MT, NC, ND, NE,NH, NJ, NM, NV, NY, OH, OK OR,PA, RI,SC, TN, TX, UT,VA, VT, WA, WI, WV, and WY

Date initiated

2008-02-27

Date posted

2008-09-23

Date terminated

2011-12-17

Location

Saint Paul, MN

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