Medline Medical Convenience Kits Recalled for Adhesive Removal Issues
Medline Industries is recalling 233 medical convenience 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 recall is classified as Class II because the products are difficult to remove and leave adhesive residue on the skin. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Medline Industries, LP is recalling 233 medical convenience kits. The affected products are labeled as FETAL SURGERY CDS-LF, MAJOR, and ABDOMINAL TRANSPLANT. The kits were distributed worldwide, including in the United States, Canada, Turkey, Australia, and the United Arab Emirates.
The recall was initiated due to reports that the products are difficult to remove from patients and leave adhesive residue on the patient's skin. The source text does not report any illnesses, injuries, or deaths associated with the use of these kits.
Healthcare providers and consumers should stop using the affected kits and contact Medline Industries for further instructions or a refund.
The recalled product
- Product
- MEDLINE medical convenience kits labeled as: 1) FETAL SURGERY CDS-LF, Medline Kit Number/SKUCDS840214R; 2) MAJOR, Medline Kit Number/SKUDYNJ904851I; 3) ABDOMINAL TRANSPLANT, Medline Kit Number/SKUDYNJ908124B.
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Kits
- Affected units
- 233
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 (13)
- Medline Product Number/SKU DYNJP6101
- UDI/DI 10198459447594 (each) 40198459447595 (case)
- Lot Number 26GBC179
- UDI/DI 10198459217623 (each) 40198459217624 (case)
- Lot Number 26HBV769
- Lot Number 26GBJ833
- Lot Number 26EBT593
- Medline Product Number/SKU DYNJP6106
- UDI/DI 10198459012648 (each) 40198459012649 (case)
- Lot Number 26DLB020
- Medline Product Number/SKU DYNJP6108
- Lot Number 26DLA431
- Lot Number 26BLA251.
Distribution
Distributed nationwide across the United States.
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