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Terminated

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

FDA Recall Z-0696-2008 · Posted 2008-01-31

Recalling FirmSmiths Medical Asd Inc
Recall StatusTerminated
Product CodeCBT
Date Initiated2007-11-21
Date Terminated2010-09-30
Product Quantity250 units

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

Firm 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.

Root Cause

Packaging process control

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K902771ARTERIAL BLOOD SAMPLING KITMedex, Inc. · 1990-11-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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