Medex MX821L 72 inch (182.9cm) Administration Sets… recallZ-1549-2008 · Smiths Medical Asd Inc · initiated Mar 24, 2008
Terminated All recalls posted in July 2008
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Smiths Medical Asd Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Packaging process control
What the company is doing
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.
Recall details
- Recall number
- Z-1549-2008
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Mar 24, 2008
- Posted by the FDA
- Jul 30, 2008
- Recalling firm
- Smiths Medical Asd Inc
- Quantity
- 350 units
- Product code
- LHI
- FDA submissions
- K790314
- Distribution
- Worldwide Distribution --- USA including states of PA, NJ, IL, MN and ND and country of Canada.
Product description
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.
Code information (models, lots, serial numbers)
Lot #1217947.
Other devices under the same FDA submission
1 device cleared under K790314 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Medex MX20846R2Icu Medical, Inc. · Filter, infusion line1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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