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U.S. Department of Health and Human Services

Class 2 Device Recall CADDSolis ambulatory infusion pumps.

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 Class 2 Recall
CADDSolis ambulatory infusion pumps.
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Date Posted October 04, 2011
Recall Status1 Terminated on July 19, 2012
Recall Number Z-0004-2012
Recall Event ID 58823
Premarket Notification
510(K) Number
K072144 
Product Classification Pump, Infusion, Pca - Product Code MEA
Product Smiths Medical, CADD®-Solis ambulatory infusion pumps, Models 2100, REF 21-2101-0200-51 and 2110, REF 21-2111-0100-51, Rx Only. Indicated for intravenous, intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site (soft tissue, body cavity/ surgical wound site), epidural space, or subarachnoid space infusion.
Code Information serial numbers: 1010145 1010247 1010276 1010305 1010335 1010523 1010555 1010807 1012986 1010168 1010248 1010277 1010306 1010337 1010524 1010556 1010808 1012987 1010169 1010249 1010278 1010307 1010338 1010525 1010557 1010809 1012988 1010170 1010250 1010279 1010308 1010340 1010526 1010558 1010810 1012989 1010171 1010251 1010280 1010309 1010341 1010527 1010559 1010811 1012990 1010172 1010252 1010281 1010310 1010342 1010528 1010560 1011814 1012991 1010173 1010253 1010282 1010311 1010343 1010529 1010561 1011815 1012992 1010174 1010254 1010284 1010312 1010344 1010530 1010562 1011816 1010175 1010255 1010285 1010314 1010345 1010531 1010563 1011817 1010176 1010256 1010286 1010315 1010346 1010532 1010564 1011818 1010177 1010257 1010287 1010316 1010347 1010533 1010565 1011819 1010178 1010258 1010288 1010317 1010349 1010535 1010566 1011820 1010179 1010259 1010289 1010318 1010350 1010536 1010567 1011821 1010180 1010260 1010290 1010319 1010351 1010537 1010568 1011822 1010181 1010261 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Recalling Firm/
Manufacturer
Smiths Medical ASD, Inc.
1265 Grey Fox Rd
Saint Paul, Minnesota 55112-6929
Consumer Instructions No consumer action necessary
Manufacturer Reason
for Recall
Reports of non-delivery/ significant under-delivery of fluids when the CADD¿ Medication Cassette Reservoir is not correctly latched to the pump. EXPANDED: On 7/14/11, Smith Medical expanded this recall to include all consignees with affected pumps.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Smiths Medical sent a customer's bulletin notice dated April 11, 2011, only to the customers who reported this issue. Smiths Medical will work directly with the five Consignees who have reported complaints for this issue. The customer was instructed to read the attached Customer Information Bulletin. If you have additional questions on how to correctly latch a cassette to the pump, than please visit the following website: https://www.smiths-medical-education.com. Smiths Medical will also provide replacement pumps, as requested. This also will be considered an extension of Smiths Medical's investigation into this issue and to further validate the effectivity of the corrective and preventative actions in actual use. For further questions please call (651) 628-7280. EXPANDED: Consignees were sent a Smith Medical " Urgent Safety Alert" letter dated June, 30, 2011. The letter was addressed to Risk/ Safety Managers, Clinicians/ Biomedical Engineering, Nursing, Pharmacy, Pain Management and Anesthesia Professionals, Medical Equipment Rental Companies, Distributors and other users of these devices. The letter described the problem and the product. It provided "Advice on Action to be Taken by the User". This included to read the attached Customer information Bulletin and to complete and return the attached Confirmation Form.
Quantity in Commerce 4536 (3792 USA, 744 OUS)
Distribution Worldwide Distribution -- (USA) nationwide including the states of AR, CA, MO, NY and WI., and the countries of BELGIUM, CANADA, SWITZERLAND, GERMANY, DENMARK, FRANCE, UNITED KINGDOM, IRELAND, ITALY, LUXEMBOURG, MALAYSIA, NETHERLANDS, NEW ZEALAND, PORTUGAL, QATAR, SAUDI ARABIA, SINGAPORE. *** EXPANDED*** AL, AK, AZ, CO, DC, FL, GA, ID, IL, IN, KY, LA, MD,MA, JI, MN, MT, NE, NH, NJ, NM, NC, OH, OK, OR, PA, RI, TN, TX, UT, VT, VA, WA, WY. UNITED ARAB EMIRATES, AUSTRIA, AUSTRALIA.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MEA and Original Applicant = SMITHS MEDICAL MD, INC.
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