Device Recall Standard Drip Administration Set 의 리콜

Recall

47474

Class 3

Z-1549-2008

2008-03-24

2008-07-30

Terminated

United States

2010-09-30

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69548

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.

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.