—#49567

Product

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

FDA product code: LRO — General Surgery Tray
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K914174
Affected lot / code info: Reorder # DYND70660, lots 06JC0016 and 06JC0017, exp. 08-08

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Medline Industries Inc
Address: 1 Medline Pl, Mundelein, Illinois 60060-4486

Distribution

Distribution pattern: Minnesota, Illinois, Wisconsin and Indiana

Timeline

Recall initiated: 2006-11-21
Posted by FDA: 2006-12-14
Terminated: 2008-01-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #49567. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.