Medline C-Section Drapes Recalled for Adhesive Removal Issues
Medline Industries is recalling C-section drapes with pouches because they are difficult to remove and leave adhesive residue on patient 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 describes the hazard as the product being difficult to remove and leaving adhesive residue on skin. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Medline Industries, LP is recalling MEDLINE DRAPE C-SECTION W/POUCH ST 7/CS, Medline Product Number/SKU DYNJP6101. The recall involves 4,765 units of the product.
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 product was distributed worldwide, including the United States, Canada, Turkey, Australia, and the United Arab Emirates.
Healthcare facilities and consumers should stop using the affected drapes. The specific lot numbers involved are 31124090032F, 31125080028F, 31126050023F, and 31126060021F. The UDI/DI codes are 10080196913589 (each) and 40080196913580 (case).
The recalled product
- Product
- MEDLINE DRAPE C-SECTION W/POUCH ST 7/CS, Medline Product Number/SKU DYNJP6101
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Drapes
- Affected units
- 4,765
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 (5)
- UDI/DI 10080196913589 (each) 40080196913580 (case)
- Lot numbers: 31124090032F
- 31125080028F
- 31126050023F
- 31126060021F.
Distribution
Distributed nationwide across the United States.
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