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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 CloraPrepsee related information
Date Initiated by FirmFebruary 12, 2003
Date PostedMarch 12, 2003
Recall Status1 Terminated 3 on August 12, 2003
Recall NumberZ-0645-03
Recall Event ID 25572
Product Classification Wound Dressing Kit - Product Code MCY
ProductSterile Dressing Change Tray with CloraPrep - Latex Free; Medline Industries, Inc., Mundelein, IL 60060-4488; 28 trays per case
Code Information reorder #DYND75221, lot 02KA0269
FEI Number 1417592
Recalling Firm/
Manufacturer		 Medline Industries Inc
One Medline Place
Mundelein IL 60060
For Additional Information ContactJoe 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
ActionRecalled 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 Commerce207 cases
DistributionNationwide and Canada
Total Product Life CycleTPLC 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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