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.

Schedule Discussion with John F. Murray, Jr.

John is currently providing telephone and face-to-face meetings to discuss:  Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.

Leave a message and we will contact you to schedule:

Corporate Office

+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TN) and Italy.