Date Initiated by Firm | March 24, 2008 |
Date Posted | July 30, 2008 |
Recall Status1 |
Terminated 3 on September 30, 2010 |
Recall Number | Z-1549-2008 |
Recall Event ID |
47474 |
510(K)Number | K790314 |
Product Classification |
IV Sets - Product Code LHI
|
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 OH 43016-1270
|
For Additional Information Contact | 614-889-2220 |
Manufacturer 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. |
FDA Determined Cause 2 | 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 in Commerce | 350 units |
Distribution | Worldwide Distribution --- USA including states of PA, NJ, IL, MN and ND and country of Canada. |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database | 510(K)s with Product Code = LHI
|