Medline RF Detect Sterile X-Ray Detectable USP Type VII Gauze; 8" x 4", 12-ply, 100% cotton sponges, 10 sponges per pack

FDA device recall Z-2321-2008 · posted 2008-09-20 · Terminated

Recall details

Recalling firm

Medline Industries Inc

Reason for recall

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

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

GDY

Quantity affected

295 cases

Distribution

California, Indiana, Missouri, Ohio, Oklahoma, Pennsylvania, Texas and Washington

Date initiated

2008-06-13

Date posted

2008-09-20

Date terminated

2009-01-09

Location

Mundelein, IL

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