Recall Z-1604-2008 ยท FRN Pump, Infusion
Smiths Medical MD, Inc.
Deltec 3000 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 numbers 21-5301-01 & 21-5306-01 The product is used for general drug delivery infusion therapies. The product is only intended to be used by trained clinicians.
| Date | Sep 23, 2008 (initiated Feb 27, 2008) |
| Status | Terminated |
| Reason | 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. |
| Root 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 thro |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K940446 | 3M MODEL 3000 & MODEL 3100 INFUSION PUMP (MODIFICATION) Minnesota Mining and Mfg. Co., Aug 15, 1994 |