Class 2 Device Recall CI Healthcare Stainless Steel Patient Transport Stretcher

• Date Initiated by Firm: February 17, 2011
• Date Posted: February 14, 2012
• Recall Status: Terminated on April 19, 2012
• Recall Number: Z-1013-2012
• Recall Event ID: 59094
• Product Classification: Stretcher, wheeled - Product Code FPO
• 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.
• Code Information: 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.
• Recalling Firm/ Manufacturer: Cardiopulmonary Instrumentation, Inc; 3002 Nw 79th Ave; Doral FL 33122-1010
• For Additional Information Contact: Robert Nunez; 305-592-8196
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Device Design
• Action: 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.
• Quantity in Commerce: 72 Units
• Distribution: Nationwide Distribution - to one distributor in Puerto Rico
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.