Z-0695-2008

Smiths Medical, Add-On Kids Kit , Blood Sampling System

Name: Z-0695-2008 Smiths Medical, Add-On Kids Kit , Blood Sampling System
Creator: Smiths Medical Asd Inc
Published: 2007-11-21
License: https://open.fda.gov/license/

Abbott Medical / initiated 2007-11-21 / Terminated / root cause: packaging

FDA source

Smiths Medical Asd Inc began a recall of Smiths Medical, Add-On Kids Kit , Blood Sampling System, Product Code: MX4037, Smiths Medical ASD, Inc, Dublin, Ohio 43016 on 2007-11-21. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0695-2008
Status: Terminated
Initiated: 2007-11-21
Posted: 2008-01-31
Terminated: 2010-09-30
Recalling firm: Abbott Medical
Product: Smiths Medical, Add-On Kids Kit , Blood Sampling System, Product Code: MX4037, Smiths Medical ASD, Inc, Dublin, Ohio 43016
Product code: CBT Arterial Blood Sampling Kit
Reason for recall: 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 tag: packaging
FDA root cause: Packaging process control
Action: 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.
Quantity in commerce: 1440 units
Distribution: Nationwide including the states of CA, DC, IL, IN, MD, MN, NC, NE, SC, and TN and Puerto Rico.
Product codes and lots: Lot Numbers: 1189082, 1231444, 1178100, and 1225588.

Product code CBT

K902771Class IIArterial Blood Sampling KitMedex, Inc. / cleared 1990-11-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)