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.

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

Interested in having a conversation?  Email us to arrange a Zoom meeting or call us at +1 781-721-2921.

office@softwarecpr.com

Corporate Office

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