Burn Relief, MODEL #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200, CATALOG #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200 --

FDA device recall Z-2731-2017 · posted 2017-06-22 · Terminated

Recall details

Recalling firm

O-Two Medical Technologies, Inc.

Reason for recall

For lack of evidence to validate effectiveness of sterilization dose, O-Two Medical Technologies Inc. hereby announces a voluntary medical device recall of the suspected batches of Burn Relief products to prevent potential contamination. .

Action taken

O-Two sent a Voluntary Recall Notification dated September 30, 2015, to all affected customers. Customers were instructed to acknowledge receipt of the recall notice by fax to 1-905-677-2035; or email to cs@otwo.com. Customers with questions should call 1-905-677-9410. For questions regarding this recall call 905-677-9410 .

Root cause

Process control

Status

Terminated

Product code

NAE

Quantity affected

624 units

Distribution

Worldwide Distribution - US (nationwide) Canada, Belgium, Norway, and Malaysia

Date initiated

2015-09-30

Date posted

2017-06-22

Date terminated

2017-09-01

Location

Mississauga, Canada