Recall – Adult Nasal Cannula

“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.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.