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Terminated

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.

FDA Recall Z-1813-2015 · Posted 2015-06-18

Recalling FirmSmiths Medical ASD, Inc.
Recall StatusTerminated
Product CodeMEA
Date Initiated2015-05-26
Date Terminated2016-05-09
Product Quantity4426 (2427 US, 1999 OUS)

Reason for Recall

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

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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 (Switzerland), DE (Germany), DK (Denmark), FR (France), GB (Great Britain), HK (Hong Kong), LB (Lebanon), NL (Netherlands), NZ (New Zealand), QA (Qatar), SA (Saudi Arabia), and SE (Sweden).

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K130394CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0Smiths Medical Asd, Inc. · 2013-12-09K072144CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE - ADMINISTRATORSmiths Medical MD, Inc. · 2008-03-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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