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

Class 2 Device Recall JASMINE Full Body (Patient) Lift

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


New Search Back to Search Results
 Class 2 Recall
JASMINE Full Body (Patient) Lift
see related information
Date Posted July 06, 2011
Recall Status1 Terminated on February 28, 2013
Recall Number Z-2741-2011
Recall Event ID 58655
Product Classification Lift, Patient, Ac-Powered - Product Code FNG
Product JASMINE Full Body (Patient) Lift, electrically-powered device with a 500 lb. weight capacity. The recalled product is an electrically-powered device either fixed or mobile, used to lift and transport patients in the horizontal or other required position from one place to another.
Code Information The model number is JASMINE and all serial numberrs are subject to recall.
Recalling Firm/
Manufacturer
Invacare Corporation
1200 Taylor St
Elyria, Ohio 44035-4190
Manufacturer Reason
for Recall
Component Defect. The rear mast connector on certain patient lifts distributed by the firm, may break. Failure of the rear mast connector, while in use would result in a patient being dropped, possibly resulting in serious injury or death to the patient or care provider.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action INVACARE contacted their customers via telephone on 4/8/2011 and 4/11/2011, and informed them of this recall. During these telephone conversations, the customers were asked to immediately cease use of the JASMINE patient lifts and to quarantine all product on-site until further notice from Invacare. The firm followed up on the telephone recall notification with a recall letter dated: April 18, 2011. The recall letter was sent via registered mail or Federal Express so as to verify customer's receipt of the recall notification. The recall letter refers the customer/care provider back to the telephone conversations. and notifies the customer of the possibility of failure of the rear mast connector which could result in a patient's possibly being dropped from the patient lift. The letter asks that the customer remove the suspect patient lift(s) from service and quarantine the device in order to prevent further use until such time as an Invacare Rep. contacts the customer by telephone and makes arrangements to pick-up the affect product. The letter is accompanied by a Response Form and a Product Tracking Sheet which lists all of the JASMINE devices shipped to the customer's facility. The customer is asked to complete the attached Response Form and to fax the form back to Invacare at the telephone number provided on the bottom of the form. The signed Response Form provides information to Invacare documenting the customers receipt of the form and understanding of the instructions contained therein, and also; the number of affected devices remaining on-hand at the customer's location, and the number of devices further distributed by the customer. In those instances in which the products have been further distributed, the customer is asked to 'carry out the instructions of the recalling firm and extend the recall to their sub-account customers.
Quantity in Commerce 274 units
Distribution Worldwide Distribution - USA including DC, FL, GA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NJ, NV, NY, OH, OK, PA, RI, SC, TN, VA, WA, and WI and the countries of Canada, Ireland, United Kingdom, Norway, Austria, Germany, and Australia.
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.
-
-