Medline Recalls Suture Removal Kits With Subpotent Iodine Concentration
Medline Industries is recalling Suture Removal Kits because the iodine concentration is below the labeled claim of 0.85%.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the rubric specifies that FDA Class II recalls with significant injury or property damage reports, or structural defects, are Severe. While no injuries are explicitly reported, the subpotent nature of a sterile medical device used for wound care in a hospital setting aligns with the higher severity criteria for Class II drug/device recalls involving efficacy failures.
Plain-English summary
Medline Industries Inc. is recalling Professional Hospital Supply Suture Removal Kits, Sterile, Single Use Only. The recall involves 779 cases of the product, which was packaged in Mexico for Professional Hospital Supply, Inc.
The recall was initiated because 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 are identified by Pack Number P888899 with Lots 17RB8659 and 17GB5162, and Pack Number P888899H with Lot 17RB8659.
The products were distributed nationwide in the USA, as well as in Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, and Turkey. Healthcare facilities and consumers should check their inventory for these specific lot and pack numbers and stop using the affected kits.
The recalled product
- Product
- Professional Hospital Supply Suture Removal Kit, Sterile, Single Use Only. Packaged in Mexico for Professional Hospital Supply, Inc., 41980 Winchester Rd., Temecula, CA 92590
- Manufacturer
- Medline Industries Inc
- Affected units
- 779
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 (3)
- Pack Number: P888899
- Lots 17RB8659
- 17GB5162 Pack Number: P888899H
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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