Z-1518-2012

8" x 4" 16-ply Dual X-Ray Gauze, hospital fold, banded in 10's; 200 pieces per bag, 10 bags per case...

Name: Z-1518-2012 8" x 4" 16-ply Dual X-Ray Gauze, hospital fold, banded in 10's; 200 pieces per bag, 10 bags per case...
Creator: International Medsurg Connection, Inc.
Published: 2012-04-09
License: https://open.fda.gov/license/

Intl. Medsurg Connection, Inc. / initiated 2012-04-09 / Terminated / root cause: manufacturing process

FDA source

International Medsurg Connection, Inc. began a recall of 8" x 4" 16-ply Dual X-Ray Gauze, hospital fold, banded in 10's; 200 pieces per bag, 10 bags per case; Distributed By: International Medsurg Connection... on 2012-04-09. The reason FDA records is "The lots of X-Ray Gauze are contaminated with foreign material, including remnants of cotton seeds and lint". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1518-2012
Status: Terminated
Initiated: 2012-04-09
Posted: 2012-05-10
Terminated: 2017-12-29
Recalling firm: Intl. Medsurg Connection, Inc.
Product: 8" x 4" 16-ply Dual X-Ray Gauze, hospital fold, banded in 10's; 200 pieces per bag, 10 bags per case; Distributed By: International Medsurg Connection, Schaumburg, IL USA 1-847-619-9926; Made in China; item IMSGZXX8416-10 For use to control bleeding and absorb fluid.
Product code: GDY Gauze/Sponge, Internal, X-Ray Detectable
Reason for recall: The lots of X-Ray Gauze are contaminated with foreign material, including remnants of cotton seeds and lint.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: International Medsurg Connection notified their direct accounts via telephone, e-mail and/or fax on April 9, 2012, informing them of the foreign material contamination of the gauze, and requesting them to quarantine all affected lots in inventory, cease distribution of the affected product, and notify any customers at the retail level to remove and discard these products. Any questions were directed to (847) 619-9926.
Quantity in commerce: 15 cases
Distribution: Nationwide Distribution including Illinois, South Carolina, Texas and Virginia
Product codes and lots: item IMSGZXX8416-10, lot number 11-6559-1

Product code GDY

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)