Recall Z-1033-2011 ยท MEA Pump, Infusion, Pca
Smiths Medical ASD, Inc.
Smiths Medical, CADD-Solis Ambulatory Infusion Pump, Model Number: 2100 and 2110, Reorder Number 21-2101-00, 21-2101-0100-50, 21-2101-0100-51, 21-2101-0200-02, 21-2101-0200-03, 21-2111-0100-51, 21-2111-0200-02, and 21-2102-51.
| Date | Feb 3, 2011 (initiated Jan 13, 2011) |
| Status | Terminated |
| Reason | Reports of the Cassette Lock mechanism on certain CADD-Solis Pumps becoming stuck in the locked position, making it nearly impossible to remove the medication cassette reservoirs (or administration set). The purpose of the Cassette Lock is to secure the medication cassette reservoir (or administration set) to the pump. |
| Root cause | Nonconforming Material/Component |
| Action | The firm, Smiths Medical, sent an "URGENT MEDICAL DEVICE CORRECTION NOTICE" dated January 13, 2011 to all consignees/customers. The notice described the product, problem, and action to be taken by the customers. The customers were instructed to have their Pumps undergo a correction which consist of removal and reattachment of the Cassette Latch handle using a new adhesive process. The customers were also instructed to remove the Pump from service if unable to remove cassette (or administration set); to inspect their inventory and identify Pumps; prepare a plan for correction of these Pump |
| Quantity | 2903 (2539 US; 364 OUS) |
| Distribution | Worldwide Distribution: USA including states of: AK, AZ, C, CO, DC, FL, GA, ID IL, MA, MI, MN, MO, MT, NE, NH, NM, NY, NC, OK, OR, PA, RI, TN, TX, UT, VT, VA, WA, WI, and WY; and countries including: Australia, Austria, Belgium, Canada, France, Germany, Great Britain, Ireland, Italy, Luxembourg, N |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072144 | CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE - ADMINISTRATOR Smiths Medical MD, Inc., Mar 7, 2008 |