Medline Medical Convenience Kits Recalled for Adhesive Removal Issues
Medline Industries is recalling 2,229 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 source identifies the hazard as difficulty removing the product and adhesive residue on the skin. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Medline Industries, LP is recalling 2,229 medical convenience kits. The affected products are labeled as BIRTHDAY KIT-DOUBLE BASIN-LF (SKU DYNJ16127N), NYGH-DELIVERY PACK-LF (SKU DYNJ27206D), and OB/GYN (SKU DYNJ911652). These kits were distributed worldwide, including in the United States, Canada, the Turks and Caicos Islands, 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 this issue.
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) BIRTHDAY KIT-DOUBLE BASIN-LF, Medline Kit Number/SKU DYNJ16127N; 2) NYGH-DELIVERY PACK-LF, Medline Kit Number/SKU DYNJ27206D; 3) OB/GYN, Medline Kit Number/SKU DYNJ911652.
- Manufacturer
- Medline Industries, LP
- Affected units
- 2,229
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 (18)
- Medline Kit Number/SKU DYNJ16127N
- UDI/DI 10198459449826 (each) 40198459449827 (case)
- Lot Number 26FBB857
- Lot Number 26EBA908
- Lot Number 26CBV797
- Lot Number 26ABM708
- Lot Number 25KBQ582
- Medline Kit Number/SKU DYNJ27206D
- UDI/DI 10198459353611 (each) 40198459353612 (case)
- Lot Number 26GBV395
- Lot Number 26FBO061
- Lot Number 26DBF331
- Lot Number 26BBT983
- Lot Number 25LBJ546
- Lot Number 25KBK623
- Medline Kit Number/SKU DYNJ911652
- UDI/DI 10198459481673 (each) 40198459481674 (case)
- Lot Number 26DME349.
Distribution
Distributed nationwide across the United States.
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