FDA Medical Device Recalls (openFDA)
Smiths Medical Asd Inc: Smiths Medical, Add-On Kids Kit , Blood Sampling System, Product Code: MX4037, Smiths Medical ASD, Inc, Dublin, Ohio 43016
- Recall number
- Z-0695-2008
- Recalling firm
- Smiths Medical Asd Inc
- Product
- Smiths Medical, Add-On Kids Kit , Blood Sampling System, Product Code: MX4037, Smiths Medical ASD, Inc, Dublin, Ohio 43016
- Status
- Terminated
- Initiated
- 2007-11-21
- Posted
- 2008-01-31
- Terminated
- 2010-09-30
- Reason
- 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
- 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
- 1440 units
- Distribution
- Nationwide including the states of CA, DC, IL, IN, MD, MN, NC, NE, SC, and TN and Puerto Rico.
- Lot, serial or model codes
- Lot Numbers: 1189082, 1231444, 1178100, and 1225588.
- 510(k) numbers
- ["K902771"]
- PMA numbers
- not on file
- Product code
- CBT
- Firm FEI
- 1526863
- Firm city
- Dublin
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28