Smiths Medical, CADD-Solis ambulatory infusion pumps, Models 2100, REF 21-2101-0200-51 and 2110, REF 21-2111-0100-51, Rx
FDA device recall Z-0004-2012 · posted 2011-10-04 · Terminated
Recall details
- Recalling firm
- Smiths Medical ASD, Inc.
- Reason for recall
- 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.
- Action taken
- 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 investigation into this issue and to further validate the effectivity of the corrective and preventative actions in actual use. For further questions please call (651) 628-7280. EXPANDED: Consignees were sent a Smith Medical " Urgent Safety Alert" letter dated June, 30, 2011. The letter was addressed to Risk/ Safety Managers, Clinicians/ Biomedical Engineering, Nursing, Pharmacy, Pain Management and Anesthesia Professionals, Medical Equipment Rental Companies, Distributors and other users of these devices. The letter described the problem and the product. It provided "Advice on Action to be Taken by the User". This included to read the attached Customer information Bulletin and to complete and return the attached Confirmation Form.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- MEA
- Quantity affected
- 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,
- Date initiated
- 2011-05-10
- Date posted
- 2011-10-04
- Date terminated
- 2012-07-19
- Location
- Saint Paul, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE - ADMINISTRATOR (K072144) | Smiths Medical MD, Inc. | 2008-03-07 |