Medline Drape C-SEC Fen Clear Screen Wire Recall
Medline Industries is recalling 161 units of Drape C-SEC Fen Clear Screen Wire because the product is difficult to remove and leaves 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 identifies 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 161 units of the MEDLINE DRAPE C-SEC FEN CLEAR SCRN WIRE (Medline Product Number/SKU DYNJP6106). The recall is 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, the Turks and Caicos Islands, Australia, and the United Arab Emirates. The specific lot number is 31126040011F, and the UDI/DI is 10888277370661 (each) and 20888277370668 (case).
Healthcare facilities and consumers should stop using the affected product and contact Medline Industries, LP for further instructions on how to proceed with the recall.
The recalled product
- Product
- MEDLINE DRAPE C-SEC FEN CLEAR SCRN WIRE, Medline Product Number/SKU DYNJP6106
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Drapes
- Affected units
- 161
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 (2)
- UDI/DI 10888277370661 (each) 20888277370668 (case)
- Lot numbers: 31126040011F
Distribution
Distributed nationwide across the United States.
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