CADD- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version

FDA device recall Z-1813-2015 · posted 2015-06-18 · Terminated

Recall details

Recalling firm

Smiths Medical ASD, Inc.

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

Action taken

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

Status

Terminated

Product code

MEA

Quantity affected

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, a

Date initiated

2015-05-26

Date posted

2015-06-18

Date terminated

2016-05-09

Location

Saint Paul, MN

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