Device Recall Medline Premium Wet Skin Prep Tray 의 리콜

Recall

36919

Class 2

Z-0268-2007

2006-11-21

2006-12-14

Terminated

United States

2008-01-31

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49567

The product, labeled as sterile, had not gone through the sterilization process at the time of shipment.

On 11/21/06, Medline telephoned the accounts who may have received the recalled lots, informing them that the skin scrub trays may not have gone through the full manufacturing cycle and are not sterile. They were requested to check their inventories for the two affected lots, removing any found from inventory and placing it on hold for return to Medline. The accounts were then sent a recall letter via fax on the same date, reiterating the telephone calls, and requesting the accounts to complete and fax back the attached response form, indicating amount of each lot placed on hold. Any questions were directed to Medline''s recall hotline at 866-359-1704.