Medline Suture Removal Tray Recalled for Subpotent Iodine Concentration
Medline Industries is recalling Suture Removal Trays because the Povidone-Iodine prep pads contain less iodine than labeled.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, which corresponds to a Severe rating (Score 4) in the rubric, particularly given the subpotent nature of the antiseptic agent in a sterile medical device.
Plain-English summary
Medline Industries, Inc. is recalling Medline Suture Removal Trays, sterile, single-use products. The recall involves 34,495 cases of the product.
The reason for the recall is that the titratable iodine contained in the Povidone-Iodine prep pads is below the label claim of 0.85%. This is classified as a subpotent drug issue.
The affected products were distributed nationwide in the USA, as well as in Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, and Turkey. The specific pack numbers and lot numbers are listed in the structured product information. Consumers and healthcare providers should stop using the affected lots and contact Medline Industries for further instructions.
The recalled product
- Product
- Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060
- Manufacturer
- Medline Industries Inc
- Affected units
- 34,495
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- Pack Number: Z302-R
- Lots 177B2075
- 17RB9452
- 17QB2640
- 17CB4220 Pack Number: Z302-RH
- 17CB4220
- 17NB1933
- 17MB0084
- 16LB3367
Distribution
Part of a larger recall action
This product is one of 68 recalled by Medline Industries Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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