Z-2321-2008

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

Name: Z-2321-2008 Medline RF Detect Sterile X-Ray Detectable USP Type VII Gauze; 8" x 4", 12-ply, 100% cotton sponges, 10...
Creator: Medline Industries Inc
Published: 2008-06-13
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2008-06-13 / Terminated / root cause: design

FDA source

Medline Industries Inc began a recall of 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... on 2008-06-13. The reason FDA records is "There is the potential for the RF ID tag to separate from the retaining pouch". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2321-2008
Status: Terminated
Initiated: 2008-06-13
Posted: 2008-09-20
Terminated: 2009-01-09
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
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
Product code: GDY Gauze/Sponge, Internal, X-Ray Detectable
Reason for recall: There is the potential for the RF ID tag to separate from the retaining pouch.
Root cause tag: design
FDA root cause: 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 [email protected].
Quantity in commerce: 295 cases
Distribution: California, Indiana, Missouri, Ohio, Oklahoma, Pennsylvania, Texas and Washington
Product codes and lots: reorder: NON21432RF, lots CM130002052, CM130002062, CM130002075, CM130002068, CM130002079, and CM130002110

Product code GDY

K061316Class IMedline Surgical Sponge ScannerMedline Industries, Inc. / cleared 2006-11-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)