Medline C-Section Pack Recall for Adhesive Removal Issues
Medline is recalling 222 C-Section Pack kits 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 reports that the product is difficult to remove and leaves adhesive residue on patient skin, but does not report any illnesses, injuries, or deaths.
Plain-English summary
Medline Industries, LP is recalling 222 units of MEDLINE medical convenience kits labeled as C-SECTION PACK, Product Number/SKU DYNJ48455A. The recall covers units with UDI/DI 10889942754496 (each) and 40889942754497 (case), specifically lot numbers 26FBV563 and 26ABH473.
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 products were distributed worldwide, including the United States, Canada, Turkey, Australia, and the United Arab Emirates.
Consumers and healthcare facilities should stop using the affected kits and contact Medline Industries, LP for further instructions or a return.
The recalled product
- Product
- MEDLINE medical convenience kits labeled as: C-SECTION PACK, Medline Product Number/SKU DYNJ48455A
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Kits
- Affected units
- 222
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 10889942754496 (each) 40889942754497 (case)
- Lot numbers: 26FBV563
- 26ABH473
Distribution
Distributed nationwide across the United States.
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