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U.S. Department of Health and Human Services

Class 2 Device Recall Medline Dressing Change Tray with CloraPrep

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  Class 2 Device Recall Medline Dressing Change Tray with CloraPrep see related information
Date Initiated by Firm February 12, 2003
Date Posted March 12, 2003
Recall Status1 Terminated 3 on August 12, 2003
Recall Number Z-0645-03
Recall Event ID 25572
Product Classification Wound Dressing Kit - Product Code MCY
Product Sterile Dressing Change Tray with CloraPrep - Latex Free; Medline Industries, Inc., Mundelein, IL 60060-4488; 28 trays per case
Code Information reorder #DYND75221, lot 02KA0269
Recalling Firm/
Manufacturer		 Medline Industries Inc
One Medline Place
Mundelein IL 60060
For Additional Information Contact Joe Dunn
800-950-0128
Manufacturer Reason
for Recall		 Some of the kits labeled as latex free contain latex gloves which are properly labeled.
FDA Determined
Cause 2		 Other
Action Recalled by letter dated 2/11/03. The accounts were informed that some of the suction catheter trays labeled as latex free actually contained latex gloves. The latex glove wrapper has a latex warning on it. The accounts were instructed to return any of the suspect lot of trays to Medline for replacement or credit. The recall was expanded by letterdated 3/3/03 to include the one lot of dressing change trays for the same problem and the same instructions.
Quantity in Commerce 207 cases
Distribution Nationwide and Canada
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.
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