| | Class 3 Recall
Standard Drip Administration Set |  |
| Date Posted |
July 30, 2008 |
| Recall Number |
Z-1549-2008 |
| 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. |
| Code Information |
Lot #1217947.
|
Recalling Firm/
Manufacturer |
Smiths Medical Asd Inc
6250 Shier Rings Rd
Dublin, Ohio 43016-1270 |
Reason for
Recall |
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.
|
| 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 in Commerce |
350 units |
| Distribution |
Worldwide Distribution --- USA including states of PA, NJ, IL, MN and ND and country of Canada. |
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