Leica Cryostats, used to produce frozen sample sections for biological, medical and industrial applications, including i

FDA device recall Z-1729-2019 · posted 2019-06-04 · Terminated

Recall details

Recalling firm

Leica Microsystems, Inc.

Reason for recall

The current labelling does not include any specific warning about usage of flammable freezing sprays. Such flammable freezing sprays can potentially ignite and can cause serious injuries.

Action taken

Leica Biosystems notified consignees of the recall on about 05/03/2019 via "Urgent: Medical Device Recall for Cryostat Devices" letter. Instructions included to immediately attach the provided adhesive label onto the devices and add a supplemental sheet to the current instructions for use (IFU). Consignees were also instructed to provide the recall notification to all employees who need to be aware within the organization or any organization where the affected devices have been transferred, and to complete and return the response form. The form can be faxed to +1 847-236-3747 or emailed to LMGRA@ leica-microsystems.com Questions or concerns can be directed to Adam Blunier at Adam.Blunier@leicabiosystems.com. On 09/16/2019, Leica Biosystems provided an updated "Urgent: Medical Device Recall for Cryostat Devices" letter to all affected customers. The letter contained the same instructions, but instructed customers that enlarged, updated adhesive labels were provided and should be applied to affected equipment on top of the previously provided smaller label.

Root cause

Device Design

Status

Terminated

Product code

IDP

Quantity affected

17,179 devices total (4,835 US, 12,344 OUS)

Distribution

Distributed to Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District Of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisi

Date initiated

2019-05-03

Date posted

2019-06-04

Date terminated

2023-09-28

Location

Buffalo Grove, IL