“Could this be a problem with the label printing software?” – Brian Pate
Company: Smiths Medical ASD Inc.
Date of Enforcement Report 10/10/2018
Class III:
PRODUCT
First Breath Adult Nasal Cannula, REF 001283, Non-flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style
Recall Number: Z-0071-2019
REASON
“Manufactured” and “Use By” labels are transposed incorrectly suggesting the product expires before it was manufactured.
RECALLING FIRM/MANUFACTURER
Smiths Medical ASD Inc. Minneapolis, MN on 7/6/2018
Voluntary: Firm Initiated
VOLUME OF PRODUCT IN COMMERCE
12,000 devices
DISTRIBUTION
Nationally and Internationally.