Class 2 Device Recall Deltec Micro 3100 Large Volume Infusion Pump or Graseby or 3M 3100 Large Volume Infusion Pump

• Date Initiated by Firm: February 27, 2008
• Date Posted: September 23, 2008
• Recall Status: Terminated on December 17, 2011
• Recall Number: Z-1605-2008
• Recall Event ID: 47482
• 510(K)Number: K940446
• Product Classification: Large Volume Infusion Pump - Product Code FRN
• Product: Deltec¿ Micro 3100 Large Volume Infusion Pump, CE 0473, RX Only, Smiths Medical MD, Inc. 1265 Grey Fox Road, St. Paul, MN 55112, USA, Made in UK.; ; Reorder number 21-5311-01; The product is used for general drug delivery infusion therapies. The product is only intended to be used by trained clinicians.
• Code Information: All serial numbered devices affected.
• Recalling Firm/ Manufacturer: Smiths Medical MD, Inc.; 1265 Grey Fox Rd; Saint Paul MN 55112-6929
• Manufacturer 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.
• FDA Determined Cause: Process control
• Action: 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.
• Quantity in Commerce: 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
• Total Product Life Cycle: TPLC Device Report

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.

• 510(K) Database: 510(K)s with Product Code = FRN and Original Applicant = MINNESOTA MINING AND MFG. CO.