—#66416

Product

Smiths Medical, Add-On Kids Kit , Blood Sampling System, Product Code: MX4033, Smiths Medical ASD, Inc, Dublin, Ohio 43016

FDA product code: CBT — Arterial Blood Sampling Kit
Device class: Class 1
Medical specialty: Anesthesiology
510(k) numbers: K902771
Affected lot / code info: Lot Numbers: 1189082, 1231444, 1178100, and 1225588.

Why it was recalled

Misbranded; The product codes are labeled incorrectly with a green promotional label for "New split septum sampling site. Only use needle-free access devices .......", however this product code contains a sampling site which is accessed with a shrouded needle, NOT with a needle-free access device

Root cause (FDA determination)

Packaging process control

Action the firm took

Smiths Medical mailed certified letters (Urgent Product Advisory Notifications) dated November 19, 2007, to all customers that received the affected lot. Firms are instructed to make the field correction (extra label removal) or mail the product back to Smiths for the correction.

Recalling firm

Firm: Smiths Medical Asd Inc
Address: 6250 Shier Rings Rd, Dublin, Ohio 43016-1270

Distribution

Distribution pattern: Nationwide including the states of CA, DC, IL, IN, MD, MN, NC, NE, SC, and TN and Puerto Rico.

Timeline

Recall initiated: 2007-11-21
Posted by FDA: 2008-01-31
Terminated: 2010-09-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #66416. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.