FDA Medical Device Recalls (openFDA)
Smiths Medical Asd Inc: Medex MX821L 72 inch (182.9cm) Administration Sets, Standard Drip, Sterile Single Use, Latex Free device packaged 25 units per case. Used to administer fluids.
- Recall number
- Z-1549-2008
- Recalling firm
- Smiths Medical Asd Inc
- Product
- Medex MX821L 72 inch (182.9cm) Administration Sets, Standard Drip, Sterile Single Use, Latex Free device packaged 25 units per case. Used to administer fluids.
- Status
- Terminated
- Initiated
- 2008-03-24
- Posted
- 2008-07-30
- Terminated
- 2010-09-30
- Reason
- Misbranded/mispackaged device was distributed. Product labeled to contain 72 inch Standard Drip ( IV) Administration Sets, actually contained 60 inch (IV) administration sets with a' Y' site.
- Root cause
- Packaging process control
- Action
- On 3/24/2008, the firm issued separate URGENT: PRODUCT RECALL NOTIFICATIONs sent via certified mail to their distributor and medical customers. Both recall notifications inform the customers of this labeling error and ask that the customers: 1) check their inventories for the presence of the suspect product; 2) complete and return the attached 'Product Recall Notification Response Form'; and 3) make arrangements to return any unused affected product to the recalling firm in exchange for a credit or replacement product. In addition, the distributors are asked to either provide the recalling firm with a list of their sub-account customers so that Smith Medical can contact the enduser customers and notify them of the recall, or as an alternative measure, the distributor can notify their branches and customers directly, via their own certified letter.
- Quantity
- 350 units
- Distribution
- Worldwide Distribution --- USA including states of PA, NJ, IL, MN and ND and country of Canada.
- Lot, serial or model codes
- Lot #1217947.
- 510(k) numbers
- ["K790314"]
- PMA numbers
- not on file
- Product code
- LHI
- 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