Medline C-Section Tray Kits Recalled for Adhesive Removal Issues
Medline is recalling 108 C-Section Tray kits because they are difficult to remove from patients and leave adhesive residue on the skin.
The agency’s classification
FDA (Devices): 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The source reports that the product is difficult to remove and leaves adhesive residue on the skin, but does not report any illnesses, injuries, or deaths.
Plain-English summary
Medline Industries, LP is recalling 108 medical convenience kits labeled as C-SECTION TRAY-LF, Medline Kit Number/SKU OBN471K. The recall was initiated due to reports that the product is difficult to remove from patients and leaves adhesive residue on the patient's skin.
The affected kits were distributed worldwide, including in the United States, Canada, Turkey, Australia, and the United Arab Emirates. The specific lot numbers involved are 26BBR121, 25LBL570, and 25JBN486.
Healthcare providers and consumers should stop using these kits and contact Medline Industries for further instructions on how to proceed.
The recalled product
- Product
- MEDLINE medical convenience kits labeled as: C-SECTION TRAY-LF, Medline Kit Number/SKU OBN471K
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Kits
- Affected units
- 108
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 (4)
- UDI/DI 10889942132669 (each) 40889942132660 (case)
- Lot numbers: 26BBR121
- 25LBL570
- 25JBN486.
Distribution
Distributed nationwide across the United States.
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