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U.S. Department of Health and Human Services

Class 2 Device Recall Medline Premium Wet Skin Prep Tray

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  Class 2 Device Recall Medline Premium Wet Skin Prep Tray see related information
Date Initiated by Firm November 21, 2006
Date Posted December 14, 2006
Recall Status1 Terminated 3 on January 31, 2008
Recall Number Z-0268-2007
Recall Event ID 36919
510(K)Number K914174  
Product Classification surgical prep tray - Product Code LRO
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
Code Information Reorder # DYND70660, lots 06JC0016 and 06JC0017, exp. 08-08
Recalling Firm/
Manufacturer		 Medline Industries Inc
1 Medline Pl
Mundelein IL 60060-4486
For Additional Information Contact
866-359-1704
Manufacturer Reason
for Recall		 The product, labeled as sterile, had not gone through the sterilization process at the time of shipment.
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LRO and Original Applicant = MEDICAL DEVICE INSPECTION CO., INC.
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