Recall Z-1813-2015 ยท MEA Pump, Infusion, Pca
Smiths Medical ASD, Inc.
CADD- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
| Date | Jun 18, 2015 (initiated May 26, 2015) |
| Status | Terminated |
| Reason | Smiths Medical has become aware of an issue with an intermittent occurrence of binding of the locking assembly on some CADD-Solis pumps. Binding of the Cassette/ Keypad Lock can occur after latching the CADD-Solis Medication Cassette Reservoir or Administration Set disposable to the pump. When binding occurs, it can prevent the key from fully rotating the Cassette/ Keypad Lock to the locked (e |
| Root cause | Nonconforming Material/Component |
| Action | Consignees were sent on 5/26/2015 a Smiths Medical "Urgent Medical Device Recall Notice" letter dated 26 May 2015. The letter described the problem and the device involved in the recall. The letter provided "Advise on Action to be taken by the User" and " Transmission of this Urgent Medical Device Recall Notice". Consignees were requested to complete and return the Confirmation Form. For questions they can contact Smiths Medical's Customer Service Department at 1-800-258-5361, press 2, then press 1. |
| Quantity | 4426 (2427 US, 1999 OUS) |
| Distribution | Worldwide Distribution-US (nationwide) including the states of AL, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, IA, KS, LA, MA, MI, MN, MS, MO, NE, NM, NY, NC, ND, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, and WI, and the countries of AT (Austria), AU (Australia), BE (Belgium), CA (Canada), CH (Switzerlan |
| FDA record | Open on fda.gov |