Key Takeaway

Medline All Purpose Instrument Tray, Sterile. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060 by Medline Industries Inc was recalled on September 21, 2017. The hazard: Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

FDA Drug Class II Terminated

Medline All Purpose Instrument Tray, Sterile. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060

Recalled: September 21, 2017 ~250 cases units affected D-0277-2018

Description

Medline All Purpose Instrument Tray, Sterile. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060

Hazard / Reason

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

Class II: Product that may cause temporary or medically reversible health consequences.

Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.

Products Affected

Medline All Purpose Instrument Tray, Sterile. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060

Drugs

Company Information

Medline Industries Inc

Mundelein, IL, United States

View all 75 recalls by Medline Industries Inc →

Distribution

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

Related Recalls

FDA Drug Class II

Hand Sanitizer Foam (ethyl alcohol), 62% v/v, packaged in a) 1.5 Oz. cans, NDC 53329-970-12; b) 8 Oz. (227 g) cans, NDC 53329-970-08; and c) 16 Oz. (453 g) cans, NDC 53329-970-06; Manufactured for: M

November 8, 2021
FDA Drug Class III

READYPREP CHG, 2% Chlorhexidine Gluconate Cloth, 2 9x10.5 in (22.9x26.7 cm) Disposable Cloths, Non-Sterile, Single Use Only, Manufactured by Medline Industries, Inc., Northfield, IL 60093 USA. NDC: 5

May 14, 2021
FDA Drug Class II

SparkleFresh Fluoride Toothpaste, Sodium Monofluorophosphate 0.76%, a) 17 g tube (NDC 53329-083-92, product number NONTP6I), b) 24 g tube (NDC 53329-083-93, product number NONTP85I), c) 42.5 g (NDC 53

September 17, 2018
FDA Drug Class II

PVP Scrub Solution, Povidone Iodine, 7.5% (equivalent to 0.75% available iodine), 4 FL OZ bottle, Manufactured in USA by Medline Industries, Inc., Northfield, IL 60093; Product Number MDS093945; NDC 5

February 15, 2018
FDA Drug Class II

Medline Pediatric IV Kit. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093

September 21, 2017
FDA Drug Class II

Medline Suture Removal Tray. Sterile. Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060

September 21, 2017

Frequently Asked Questions

Is this recall still active?

Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.

How do I check if my product is affected?

Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.

What remedy is available for this recall?

Check the remedy section above or contact the manufacturer directly for current remedy options.

Where can I find the original recall notice?

This recall was issued by FDA Drug. Visit the agency's official website for the original notice.

Data sourced from FDA Drug Enforcement. Recall information may not reflect the most current status. RecallDex is not affiliated with any US government agency. Contact the manufacturer or relevant agency for the latest information.