Rose Bed 의 리콜

Recall

66137

Class 2

Z-0363-2014

2013-10-23

2013-11-19

Terminated

United States

2014-05-16

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121538

It was reported that the siderail may appear latched when it is not, due to lack of proper preventive maintenance. this might result in bruises and/or lacerations to a patient who is leaning against the siderails if the siderail releases. additionally, the siderail may not effectively constrain a patient to prevent them from rolling or falling off the bed.

Stryker Medical sent a Medical Device Notification letter dated October 23, 2013, to all affected consignees. The letter described the recalled product, potential injuries associated with the side rail sticking, as well as providing preventive measures to be taken to mitigate the risk. Consignees were directed to locate the beds listed in this notice, ensure that the siderails have been inspected and adjusted, as required, continue to routinely inspect the siderails and functionality using the enclosed, enhanced product maintenance information. Problems and concerns should be addressed to Stryker at (1-800-327-0770, option 2). Consignees were asked to Fax (269-488-8691) or e-mail (ProductFieldAction@stryker.com ) the enclosed return form and directed to forward the notice if product was further distributed and advise Stryker of the beds new location. For questions regarding this recall call 269-324-6609.