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.
FDA Recall Z-1517-2012 · Posted 2012-05-10
Recalling FirmInternational Medsurg Connection, Inc.
Recall StatusTerminated
Product CodeGDY
Date Initiated2012-04-09
Date Terminated2017-12-29
Product Quantity276 cases
Reason for Recall
The lots of X-Ray Gauze are contaminated with foreign material, including remnants of cotton seeds and lint.
Firm 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.
Root Cause
Process control
Distribution Pattern
Nationwide Distribution including Illinois, South Carolina, Texas and Virginia
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.