Medline Medical Convenience Kits Recalled for Adhesive Removal Issues
Medline Industries is recalling specific medical convenience 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 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 545 units of four specific medical convenience kits: LAPAROTOMY GYN CDS, GYN ROBOTIC PK-LF, TAH PACK, and TUBAL LIGATION RFD. 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 affected kits were distributed worldwide, including in the United States, Canada, Turkey, Australia, and the United Arab Emirates. The source text does not report any illnesses, injuries, or deaths associated with this recall.
Healthcare providers and consumers should check their inventory for the specific Medline kit numbers and lot numbers listed in the official recall notice. If the products are found, they should be removed from use and returned to Medline Industries for further instructions.
The recalled product
- Product
- MEDLINE medical convenience kits labeled as: 1) LAPAROTOMY GYN CDS, Medline Kit Number/SKU CDS983529O; 2) GYN ROBOTIC PK-LF, Medline Kit Number/SKU DYNJ52432M; 3) TAH PACK, Medline Kit Number/SKU DYNJ60646A; 4) TUBAL LIGATION RFD, Medline Kit Number/SKU DYNJ906291F.
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Kits
- Affected units
- 545
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 (13)
- Medline kit number/SKU CDS983529O
- UDI/DI 10198459603464 (each) 40198459603465 (case)
- Lot Number CDS983529O
- Medline kit number/SKU DYNJ52432M
- UDI/DI 10198459508035 (each) 40198459508036 (case)
- Lot Number DYNJ52432M
- Medline kit number/SKU DYNJ60646A
- UDI/DI 10198459363658 (each) 40198459363659 (case)
- Lot Number DYNJ60646A
- Medline kit number/SKU DYNJ906291F
- UDI/DI 10198459419591 (each) 40198459419592 (case)
- Lot Number DYNJ906291F
- Lot Number DYNJ906291F.
Distribution
Distributed nationwide across the United States.
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