Medline Heart Transplant Biopsy Kit regulatory clearance rescinded
Medline Industries is recalling Heart Transplant Biopsy Kit (Model DYNJ37543A) after the FDA rescinded regulatory clearances for certain Control Syringes, Guidewires, and High-Pressure Tubing used in the kit.
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: This is an FDA Class II recall involving rescission of regulatory clearances. The source text does not report any injuries, illnesses, or deaths. The hazard is regulatory non-compliance rather than a documented safety event, placing it in the Moderate category.
Plain-English summary
Medline Industries, LP is recalling the Heart Transplant Biopsy Kit, Model Number DYNJ37543A (Lot Number 24DDA193). The FDA has rescinded the 510(k) regulatory clearances for certain Control Syringes, Guidewires, and High-Pressure Tubing components of this kit.
A total of 39 units were distributed nationwide across the United States. Patients who have received or may receive this product should consult their healthcare provider for guidance on next steps.
Healthcare facilities that have this product in stock should discontinue use immediately and contact Medline Industries, LP for instructions on product return or replacement.
The recalled product
- Product
- Medline Kits: 1) HEART TRANSPLANT BIOPSY, Model Number: DYNJ37543A
- Manufacturer
- Medline Industries, LP
- Affected units
- 39
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 (4)
- 1) DYNJ37543A
- UDI-DI: 10193489919561(each)
- 40193489919562(case)
- Lot Number: 24DDA193
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 22 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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