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U.S. Department of Health and Human Services

Class 2 Device Recall Medline RF Detect Sterile XRay Detectable USP Type VII Gauze

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  Class 2 Device Recall Medline RF Detect Sterile XRay Detectable USP Type VII Gauze see related information
Date Initiated by Firm June 13, 2008
Date Posted September 20, 2008
Recall Status1 Terminated 3 on January 09, 2009
Recall Number Z-2321-2008
Recall Event ID 48749
510(K)Number K061316  
Product Classification Gauze/sponge, internal, x-ray detectable - Product Code GDY
Product Medline RF Detect Sterile X-Ray Detectable USP Type VII Gauze; 8" x 4", 12-ply, 100% cotton sponges, 10 sponges per pack, 80 packs per case; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA, Made in China; reorder: NON21432RF
Code Information reorder: NON21432RF, lots CM130002052, CM130002062, CM130002075, CM130002068, CM130002079, and CM130002110 
Recalling Firm/
Manufacturer		 Medline Industries Inc
1 Medline Pl
Mundelein IL 60060
For Additional Information Contact Ms. Kathy Dunne
866-359-1704
Manufacturer Reason
for Recall		 There is the potential for the RF ID tag to separate from the retaining pouch.
FDA Determined
Cause 2		 Device Design
Action Initially a recall letter dated 6/13/08 was sent to the direct accounts identifying 5 lots of affected lots with two reorder numbers involved, explaining that there was a lack of integrity of the retaining pouch material for the RFID gauze, and that there was a potential for the RFID tag to separate from the retaining pouch during use. It was subsequently discovered that there was only one reorder number affected by the problem and that an additional lot had been gamma sterilized. Therefore a second letter dated 6/19/08, listing the correct reorder number and the six affected lots, was sent via FedEx overnight on the same date. The accounts were requested to remove RFID gauzes with the listed lot numbers from all stock rooms, materials storage, and OR's, and return it to Medline for replacement. The accounts were requested to complete the enclosed response sheet and fax it back to Medline at 847-643-4482, indicating the amount and lot numbers of the gauzes being returned. Any questions were directed to 866-359-1704, between 8:00 AM and 5:00 PM CST. Distributors were requested to notify their accounts of the recall. If you have questions about this recall, contact Kathy Dunne at 847-970-4678 or at kdunne@medline.com.
Quantity in Commerce 295 cases
Distribution California, Indiana, Missouri, Ohio, Oklahoma, Pennsylvania, Texas and Washington
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 = GDY and Original Applicant = MEDLINE INDUSTRIES, INC.
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