—#69548

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.

FDA product code: LHI — Set, I.V. Fluid Transfer
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K790314
Affected lot / code info: Lot #1217947.

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.

Root cause (FDA determination)

Packaging process control

Action the firm took

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.

Recalling firm

Firm: Smiths Medical Asd Inc
Address: 6250 Shier Rings Rd, Dublin, Ohio 43016-1270

Distribution

Distribution pattern: Worldwide Distribution --- USA including states of PA, NJ, IL, MN and ND and country of Canada.

Timeline

Recall initiated: 2008-03-24
Posted by FDA: 2008-07-30
Terminated: 2010-09-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #69548. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.