FDA Device

8" x 4" 16-ply 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 IMSGZX8416-10 For use to control bleeding and absorb fluid.

Hazard

The lots of X-Ray Gauze are contaminated with foreign material, including remnants of cotton seeds and lint.

What You Should Do

Remedy

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.

Products

8" x 4" 16-ply 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; ite
Brand
International Medsurg Connection, Inc.
UPC
item IMSGZX8416-10, lot numbers 11-6362-1, 11-6465-1, 11-6559-1

Units Affected

276 cases