Device Recall MicroAire Pneumatic Impactor 의 리콜

Recall

73661

Class 2

Z-1834-2016

2016-03-11

2016-05-27

Terminated

United States

2017-02-14

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144676

Microaire discovered that 20 suspect impactor instruments ( microaire pneumatic impactor) were shipped to end users and were missing the lock and unlock symbol markings on them.

MicroAire sent an Urgent Medical Device Recall letter dated March 28, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. We request that you please respond to this letter promptly to determine how many of these units you have and will be returning to MicroAire. Upon return of the instrument to MicroAire, MicroAire will provide you with replacements. Please complete and send back to MicroAire page two of this letter, indicating that you do have this instrument at your facility and whether you will be returning the instrument for replacement. You can email the form to MicroAire Customer Service at notification@microaire.com or fax the form to 1-800-648-4309. You can contact MicroAire Customer Service at 1-800-722-0822 in the United States or 1-434-975-8000 outside the United States, between the hours of 8:30 AM and 5:30 PM (ET) Monday through Friday if you have any questions.