PlainRecalls
FDA Drug Moderate Class II Terminated

Medline Suture Removal Kit, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060

Reported: February 7, 2018 Initiated: September 21, 2017 #D-0294-2018

Product Description

Medline Suture Removal Kit, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060

Reason for Recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Details

Recalling Firm
Medline Industries Inc
Units Affected
1,250 cases
Distribution
Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey
Location
Northfield, IL

Frequently Asked Questions

What product was recalled?
Medline Suture Removal Kit, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060. Recalled by Medline Industries Inc. Units affected: 1,250 cases.
Why was this product recalled?
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Which agency issued this recall?
This recall was issued by the FDA Drug on February 7, 2018. Severity: Moderate. Recall number: D-0294-2018.