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Terminated

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.

FDA Recall Z-0004-2012 · Posted 2011-10-04

Recall StatusTerminated
Product CodeMEA
Date Initiated2011-05-10
Date Terminated2012-07-19
Product Quantity4536 (3792 USA, 744 OUS)

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.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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