—#72056

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

FDA product code: GDY — Gauze/Sponge, Internal, X-Ray Detectable
Device class: Class 1
Medical specialty: General, Plastic Surgery
510(k) numbers: K061316
Affected lot / code info: reorder: NON21432RF, lots CM130002052, CM130002062, CM130002075, CM130002068, CM130002079, and CM130002110

Why it was recalled

There is the potential for the RF ID tag to separate from the retaining pouch.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Medline Industries Inc
Address: 1 Medline Pl, Mundelein, Illinois 60060

Distribution

Distribution pattern: California, Indiana, Missouri, Ohio, Oklahoma, Pennsylvania, Texas and Washington

Timeline

Recall initiated: 2008-06-13
Posted by FDA: 2008-09-20
Terminated: 2009-01-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #72056. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.