• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall CI Healthcare Stainless Steel Patient Transport Stretcher

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
 Class 2 Recall
CI Healthcare Stainless Steel Patient Transport Stretcher
see related information
Date Posted February 14, 2012
Recall Status1 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, Florida 33122-1010
Consumer Instructions Contact the recalling firm for information
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 2
DESIGN: 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 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.
-
-