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U.S. Department of Health and Human Services

Class 2 Device Recall Medline 8Fr Suction Catheter Kit

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  Class 2 Device Recall Medline 8Fr Suction Catheter Kit 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-0644-03
Recall Event ID 25572
510(K)Number K822510  
Product Classification Catheter, Irrigation - Product Code GBX
Product Sterile 8 Fr Suction Catheter Kit - Latex Free; Medline Industries, Inc., Mundelein, IL 60060-4488; 50 kits per case
Code Information reorder #DYND40978, lot 02IA0387
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 753 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.
510(K) Database 510(K)s with Product Code = GBX and Original Applicant = MEDINE DYNACOR
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