CI healthcare***Model: CI8092***S/N: 5-60-85-044 MFD: JUN…

Date posted by the FDA

Feb. 14, 2012

Status

Terminated

Filed by

Cardiopulmonary Instrumentation, Inc

Product

CI healthcare***Model: CI8092***S/N: 5-60-85-044 MFD: JUN, 2010 MADE IN CHINA***cihealthcare.com This stainless steel stretcher is used for transporting patients.

Reason

Cardiopulmonary Instrumentation, Inc. dba CI Healthcare, Miami, FL, is recalling their Stainless Steel Patient Transport Stretcher, model # CI-8092, Lot 002, because of a malfunction that occurs when weight is applied to the backrest. This malfunction causes the backrest support bar, when secured in the first hook, to fall to a flat position.

Distribution pattern

Nationwide Distribution - to one distributor in Puerto Rico

Quantity

72 Units

Codes and lots

Catalog # CI-8092, Lot # 002, Serial #'s: 5-02-92-489, 5-60-85-044, 5-02-40-687, 5-39-51-261, 5-87-72-685, 5-70-66-682, 5-83-08-847, 5-68-87-204, 5-23-81-803, 5-09-48-748, 5-46-83-142, 5-97-10-627, 5-40-10-097, 5-58-95-742, 5-42-38-793, 5-01-48-417, 5-57-51-677, 5-31-07-403, 5-41-68-771, 5-55-89-200, 5-02-04-936, 5-00-36-598, 5-29-04-097, 5-33-44-600, 5-44-36-010, 5-50-54-239, 5-08-76-966, 5-45-28-563, 5-28-92-924, 5-70-91-773, 5-70-20-478, 5-47-73-702, 5-14-47-739, 5-06-38-206, 5-60-94-228, 5-44-44-162, 5-86-06-465, 5-76-88-888, 5-72-01-700, 5-88-02-542, 5-83-56-148, 5-03-63-494, 5-84-23-417, 5-87-09-630, 5-32-40-372, 5-49-44-489, 5-01-76-666, 5-40-08-584, 5-91-42-591, 5-32-95-591, 5-49-12-189, 5-29-86-200, 5-58-40-808, 5-84-08-385, 5-04-69-827, 5-71-18-330, 5-13-18-375, 5-74-67-486, 5-08-13-310, 5-04-26-945, 5-76-35-146, 5-43-18-883, 5-61-74-389, 5-02-88-727, 5-12-31-931, 5-10-62-445, 5-90-40-312, 5-83-76-170, 5-64-45-267, 5-54-92-118, 5-53-46-840, 5-77-99-209.

Recall started

Feb. 17, 2011

Device type

Stretcher, Wheeled

Root cause (FDA)

Device Design

What the company told customers

CI Healthcare sent an "URGENT RECALL NOTIFICATION" letter dated February 17, 2011, to its customer. The letter describes the product, problem and actions to be taken. The customer were instructed to do the following: 1) Examine their inventory and isolate the product(s). 2) If they have distributed any of the products to other services or facilities, please forward this information as appropriate. 3) Discontinue use of the product until a correction has been properly executed and 4) Complete and return the "Recall Response Form" as soon as possible. Should you have any questions, please call Robert Nunez at (305) 592-8196.

Recall number

Z-1013-2012

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-1013-2012. The agency record governs; check it and the company before acting.