Device Recall Negative Pressure Wound Therapy Powered Suction Pump 의 리콜

Recall

63064

Class 2

Z-0009-2013

2012-08-31

2012-10-04

Terminated

United States

2017-12-27

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112429

Accuro has received reports of some apex pumps either failing to operate or malfunctioning, at times without notifying the user of such failure or malfunction on the unit's display screen.

The firm, Accuro, sent an "Urgent: Medical Device Recall" letter dated August 30, 2012 to the customers via e-mail on August 31, 2012. The letter describes the product, problem and actions to be taken. The customers were instructed to remove all devices from use immediately; to immediately complete and return the enclosed Accuro response form via email to; (customer.service@accuromedical.com) or fax to: (1-800-866-0545) . Note: the form still needs to be returned even if you no longer have or use the device. Upon receipt, Customer Service will call the account with instructions to arrange for all devices to be returned to Accuro. General questions were directed to Customer Service at 1-800-669-4757.