FDA Medical Device Recalls (openFDA)
International Medsurg Connection, Inc.: 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.
- Recall number
- Z-1518-2012
- Recalling firm
- International 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.
- Status
- Terminated
- Initiated
- 2012-04-09
- Posted
- 2012-05-10
- Terminated
- 2017-12-29
- 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
- 15 cases
- Distribution
- Nationwide Distribution including Illinois, South Carolina, Texas and Virginia
- Lot, serial or model codes
- item IMSGZXX8416-10, lot number 11-6559-1
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GDY
- Firm FEI
- 3000210101
- Firm city
- Schaumburg
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28