FDAClass IIFebruary 7, 2018

Medline Straight Suture Removal Tray recall: Subpotent

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

Why was Medline Straight Suture Removal Tray recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Pack Number: DYNDR1186; Lots: 17EB0360; 177B1719 Pack Number: DYNDR1186H; Lots: 16PB7974; 17EB0360

Product
Medline Straight Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
Recalling firm
Medline Industries Inc
Quantity
10,298 cases
Distribution
Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey
Recall date
February 7, 2018
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls