Medline Industries Inc Medline Premium Wet Skin Prep Tray, Sterile, Latex Free; a single use surgical convenience tray, EO sterilized; Reorder DYND70660; 20 trays per case; Medline Industries, Inc., Mundelein, IL 60060-4486 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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

Recommended Action

Per FDA guidance

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.

Distribution

As reported by FDA

IL, IN, MN, WI