CADD¿- Solis Ambulatory Infusion Pump
Medical device recall Z-1813-2015. Published in FDA’s Enforcement Report on Jun 24, 2015.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jun 24, 2015. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 35 states named
- 4426 (2427 US, 1999 OUS) how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
4426 (2427 US, 1999 OUS), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Number US 1061044 1061058 1061072 1061075 1061082 1061083 1061093 1061104 1061105 1061106 1061107 1061108 1061109 1061110 1061111 1061112 1061113 1061114 1061115 1061116 1061117 1061118 1061119 1061120 1061121 1061122 1061123…
Every code shown here, 1,993 characters
Serial Number US 1061044 1061058 1061072 1061075 1061082 1061083 1061093 1061104 1061105 1061106 1061107 1061108 1061109 1061110 1061111 1061112 1061113 1061114 1061115 1061116 1061117 1061118 1061119 1061120 1061121 1061122 1061123 1061124 1061125 1061126 1061127 1061128 1061129 1061130 1061131 1061132 1061133 1061134 1061135 1061136 1061137 1061138 1061139 1061140 1061141 1061142 1061143 1061144 1061145 1061146 1061147 1061148 1061149 1061150 1061151 1061152 1061153 1061154 1061155 1061156 1061157 1061158 1061159 1061160 1061161 1061162 1061163 1061164 1061165 1061166 1061167 1061168 1061169 1061170 1061171 1061172 1061173 1061174 1061175 1061176 1061177 1061178 1061179 1061180 1061181 1061182 1061183 1061184 1061185 1061186 1061187 1061188 1061189 1061190 1061191 1061192 1061193 1061194 1061195 1061196 1061197 1061198 1061199 1061200 1061201 1061202 1061203 1061204 1061205 1061206 1061207 1061208 1061209 1061210 1061211 1061212 1061213 1061214 1061215 1061216 1061217 1061218 1061219 1061220 1061221 1061222 1061223 1061224 1061225 1061226 1061227 1061228 1061229 1061230 1061231 1061232 1061233 1061234 1061235 1061236 1061243 1061244 1061245 1061246 1061247 1061248 1061249 1061250 1061251 1061261 1061262 1061263 1061264 1061265 1061266 1061267 1061268 1061269 1061270 1061271 1061272 1061274 1061275 1061276 1061277 1061278 1061279 1061280 1061281 1061282 1061283 1061284 1061285 1061286 1061287 1061288 1061289 1061290 1061291 1061292 1061293 1061294 1061295 1061296 1061297 1061298 1061299 1061311 1061313 1061314 1061315 1061316 1061317 1061318 1061319 1061320 1061321 1061322 1061323 1061324 1061325 1061326 1061327 1061328 1061329 1061330 1061331 1061332 1061333 1061334 1061335 1061336 1061337 1061338 1061339 1061340 1061341 1061342 1061343 1061344 1061345 1061346 1061347 1061348 1061349 1061350 1061351 1061352 1061353 1061354 1061355 1061356 1061357 1061358 1061359 1061360 1061361 1061362 1061363 1061364 1061365 1061366 1061367 1061368 1061369 1061370 1061371…
FDA’s list runs to 35,442 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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).
The states and territories these words name
35 states and territories.
Every one of them
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Florida
- Georgia
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Louisiana
- Massachusetts
- Michigan
- Minnesota
- Missouri
- Mississippi
- North Carolina
- North Dakota
- Nebraska
- New Mexico
- New York
- Ohio
- Oklahoma
- Pennsylvania
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Washington
- Wisconsin
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on May 26, 2015.
- FDA classified it on Jun 18, 2015.
- FDA’s Enforcement Report published it on Jun 24, 2015.
- FDA terminated it on May 9, 2016.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Smiths Medical ASD, Inc., of Saint Paul, MN.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 35,442 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.