Retiro De Equipo (Recall) de JASMINE Full Body (Patient) Lift

Recall

58655

Class 2

Z-2741-2011

2011-04-01

2011-07-06

Terminated

United States

2013-02-28

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99784

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.

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.