Recall Z-0004-2012 ยท MEA Pump, Infusion, Pca
Smiths Medical ASD, Inc.
Smiths Medical, CADD-Solis ambulatory infusion pumps, Models 2100, REF 21-2101-0200-51 and 2110, REF 21-2111-0100-51, Rx Only. Indicated for intravenous, intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site (soft tissue, body cavity/ surgical wound site), epidural space, or subarachnoid space infusion.
| Date | Oct 4, 2011 (initiated May 10, 2011) |
| Status | Terminated |
| Reason | Reports of non-delivery/ significant under-delivery of fluids when the CADD Medication Cassette Reservoir is not correctly latched to the pump. EXPANDED: On 7/14/11, Smith Medical expanded this recall to include all consignees with affected pumps. |
| Root cause | Nonconforming Material/Component |
| Action | Smiths Medical sent a customer's bulletin notice dated April 11, 2011, only to the customers who reported this issue. Smiths Medical will work directly with the five Consignees who have reported complaints for this issue. The customer was instructed to read the attached Customer Information Bulletin. If you have additional questions on how to correctly latch a cassette to the pump, than please visit the following website: https://www.smiths-medical-education.com. Smiths Medical will also provide replacement pumps, as requested. This also will be considered an extension of Smiths Medical's |
| Quantity | 4536 (3792 USA, 744 OUS) |
| Distribution | Worldwide Distribution -- (USA) nationwide including the states of AR, CA, MO, NY and WI., and the countries of BELGIUM, CANADA, SWITZERLAND, GERMANY, DENMARK, FRANCE, UNITED KINGDOM, IRELAND, ITALY, LUXEMBOURG, MALAYSIA, NETHERLANDS, NEW ZEALAND, PORTUGAL, QATAR, SAUDI ARABIA, SINGAPORE. *** E |
| 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 |