Z-0268-2007

Medline Premium Wet Skin Prep Tray, Sterile, Latex Free; a single use surgical convenience tray, EO...

Name: Z-0268-2007 Medline Premium Wet Skin Prep Tray, Sterile, Latex Free; a single use surgical convenience tray, EO...
Creator: Medline Industries Inc
Published: 2006-11-21
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2006-11-21 / Terminated / root cause: labeling and UDI

FDA source

Medline Industries Inc began a recall of Medline Premium Wet Skin Prep Tray, Sterile, Latex Free; a single use surgical convenience tray, EO sterilized; Reorder DYND70660; 20 trays per case; Medline... on 2006-11-21. The reason FDA records is "The product, labeled as sterile, had not gone through the sterilization process at the time of shipment". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0268-2007
Status: Terminated
Initiated: 2006-11-21
Posted: 2006-12-14
Terminated: 2008-01-31
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
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
Product code: LRO General Surgery Tray
Reason for recall: The product, labeled as sterile, had not gone through the sterilization process at the time of shipment.
Root cause tag: labeling and UDI
FDA root cause: Other
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.
Quantity in commerce: 47 cases
Distribution: Minnesota, Illinois, Wisconsin and Indiana
Product codes and lots: Reorder # DYND70660, lots 06JC0016 and 06JC0017, exp. 08-08

Product code LRO

K914174Class IISterile Disposable Wet Skin Scrub TrayMedical Device Inspection Co., Inc. / cleared 1992-02-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)