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: In

FDA device recall Z-1518-2012 · posted 2012-05-10 · Terminated

Recall details

Recalling firm

International Medsurg Connection, Inc.

Reason for recall

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

Action taken

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

Status

Terminated

Product code

GDY

Quantity affected

15 cases

Distribution

Nationwide Distribution including Illinois, South Carolina, Texas and Virginia

Date initiated

2012-04-09

Date posted

2012-05-10

Date terminated

2017-12-29

Location

Schaumburg, IL