Thermo Scientific Microm: Rotary Microtome: REF HM355S-3 Used for slicing tissue blocks.

FDA device recall Z-0039-2012 · posted 2011-10-12 · Terminated

Recall details

Recalling firm

Richard-Allan Scientific Company

Reason for recall

The firm has received two complaints of finger lacerations in operators of this device.

Action taken

ThermoFisher Scientific sent "URGENT MEDICAL DEVICE CORRECTION, RE: Thermo Scientific HM355S-3 User Safety Advisory Notice" to all affected customers. The letter states the manufacturer identified a need to enhance the safety instructions and the description of the safety devices in the user manual. It mentions the HM3555S-3 User Manual has been modified to include more specific safe work practices and a new Quick -Reference Card summarizing the manual's safety enhancements and that the changes have been included on a CD that is enclosed with the letter. The firm requests confirmation of receipt of the new User Manual and Quick-Reference Card by October 31, 2011 to be sent by FAX to (269) 372-2674 For questions on this recall call the firms Technical Support representatives at 1-800-522-7270 08:00 AM- 4:30 PM.

Root cause

Device Design

Status

Terminated

Product code

IDO

Quantity affected

786

Distribution

Worldwide Distribution: Nationwide distribution; including the country of Canada.

Date initiated

2011-08-12

Date posted

2011-10-12

Date terminated

2013-07-25

Location

Kalamazoo, MI