Recall Z-1517-2012 ยท GDY Gauze/Sponge, Internal, X-Ray Detectable
International Medsurg Connection, Inc.
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.
| Date | May 10, 2012 (initiated Apr 9, 2012) |
| Status | Terminated |
| Reason | The lots of X-Ray Gauze are contaminated with foreign material, including remnants of cotton seeds and lint. |
| 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 | 276 cases |
| Distribution | Nationwide Distribution including Illinois, South Carolina, Texas and Virginia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.