510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Z-1013-2012

CI healthcare***Model: CI8092***S/N: 5-60-85-044 MFD: JUN, 2010 MADE IN CHINA***cihealthcare.com This...

Cardiopulmonary Instrumentation / initiated 2011-02-17 / Terminated / root cause: design
FDA source (opens on fda.gov)

Cardiopulmonary Instrumentation, Inc began a recall of 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... on . The reason FDA records is "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-1013-2012
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Cardiopulmonary Instrumentation
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.
Product code
FPO Stretcher, Wheeled
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.
Root cause tag
design
FDA root 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
Product 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.