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.

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

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