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U.S. Department of Health and Human Services

Class 2 Device Recall 8" x 4" 16ply Dual XRay Gauze

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 Class 2 Device Recall 8" x 4" 16ply Dual XRay Gauzesee related information
Date Initiated by FirmApril 09, 2012
Date PostedMay 10, 2012
Recall Status1 Terminated 3 on December 29, 2017
Recall NumberZ-1518-2012
Recall Event ID 61681
Product Classification Gauze/sponge, internal, x-ray detectable - Product Code GDY
Product8" 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.
Code Information item IMSGZXX8416-10, lot number 11-6559-1
Recalling Firm/
Manufacturer		 International Medsurg Connection, Inc.
935 N Plum Grove Rd Ste F
Schaumburg IL 60173
For Additional Information Contact
847-619-9926
Manufacturer Reason
for Recall		The lots of X-Ray Gauze are contaminated with foreign material, including remnants of cotton seeds and lint.
FDA Determined
Cause 2		Process control
ActionInternational 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 Commerce15 cases
DistributionNationwide Distribution including Illinois, South Carolina, Texas and Virginia
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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