Smiths Medical, CADD-Solis Ambulatory Infusion Pump, Model Number: 2100 and 2110, Reorder Number 21-2101-00, 21-2101-010

FDA device recall Z-1033-2011 · posted 2011-02-03 · Terminated

Recall details

Recalling firm

Smiths Medical ASD, Inc.

Reason for recall

Reports of the Cassette Lock mechanism on certain CADD-Solis Pumps becoming stuck in the locked position, making it nearly impossible to remove the medication cassette reservoirs (or administration set). The purpose of the Cassette Lock is to secure the medication cassette reservoir (or administration set) to the pump.

Action taken

The firm, Smiths Medical, sent an "URGENT MEDICAL DEVICE CORRECTION NOTICE" dated January 13, 2011 to all consignees/customers. The notice described the product, problem, and action to be taken by the customers. The customers were instructed to have their Pumps undergo a correction which consist of removal and reattachment of the Cassette Latch handle using a new adhesive process. The customers were also instructed to remove the Pump from service if unable to remove cassette (or administration set); to inspect their inventory and identify Pumps; prepare a plan for correction of these Pumps; complete and return the attached CONFIRMATION FORM via fax to 1-800-237-8033 or by email to CADDDSolis_CassetteLock@smiths-medical.com, and if they have distributed the affected product to other persons or facilities, promptly forward this notice to the recipients. If you should have any questions regarding this information, please contact Smith Medical at 1-866-216-8806.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

MEA

Quantity affected

2903 (2539 US; 364 OUS)

Distribution

Worldwide Distribution: USA including states of: AK, AZ, C, CO, DC, FL, GA, ID IL, MA, MI, MN, MO, MT, NE, NH, NM, NY, NC, OK, OR, PA, RI, TN, TX, UT, VT, VA, WA, WI, and WY; and countries including:

Date initiated

2011-01-13

Date posted

2011-02-03

Date terminated

2012-04-17

Location

Saint Paul, MN

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