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Terminated

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 Recall Z-0268-2007 · Posted 2006-12-14

Recall StatusTerminated
Product CodeLRO
Date Initiated2006-11-21
Date Terminated2008-01-31
Product Quantity47 cases

Reason for Recall

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

Firm Action

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.

Root Cause

Other

Distribution Pattern

Minnesota, Illinois, Wisconsin and Indiana

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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