Medline C-Section Drapes Recalled for Adhesive Removal Issues
Medline Industries is recalling C-section drapes that 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 patient skin. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Medline Industries, LP is recalling 2,569 units of MEDLINE DRAPE C-SECTION FEN CLR SCREEN W (Product Number/SKU DYNJP6108). The recall involves specific lot numbers 45025120094 and 45025120253, identified by UDI/DI 10888277668843 (each) and 20888277668840 (case).
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 units were distributed worldwide, including the United States, Canada, the Turks and Caicos Islands, Australia, and the United Arab Emirates.
Healthcare facilities and consumers should stop using the affected drapes and contact Medline Industries for further instructions or a return.
The recalled product
- Product
- MEDLINE DRAPE C-SECTION FEN CLR SCREEN W, Medline Product Number/SKU DYNJP6108
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Drapes
- Affected units
- 2,569
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)
- UDI/DI 10888277668843 (each) 20888277668840 (case)
- Lot numbers: 45025120094
- 45025120253
Distribution
Distributed nationwide across the United States.
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