FDA-Device2015-06-24Class II
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.
Smiths Medical ASD, Inc.
Hazard
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
Sold states
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).
Affected count
4426 (2427 US, 1999 OUS)
Manufactured in
1265 Grey Fox Rd, Saint Paul, MN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1813-2015Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief