Recall Z-1549-2008 ยท LHI Set, I.V. Fluid Transfer
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.
| Date | Jul 30, 2008 (initiated Mar 24, 2008) |
| Status | Terminated |
| 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 |
| Quantity | 350 units |
| Distribution | Worldwide Distribution --- USA including states of PA, NJ, IL, MN and ND and country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K790314 | FLUID ADMINISTRATION SETS, 15 MICRON Medex, Inc., Mar 6, 1979 |