Medline Catheterization and Angiography Kits Regulatory Clearance Rescinded
Medline Industries has had its 510(k) regulatory clearances rescinded for certain Control Syringes, Guidewires, and High-Pressure Tubing used in a large number of catheterization and angiography kits. The kits are distributed nationwide.
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Our severity reasoning: This is an FDA Class II recall in which regulatory clearances have been rescinded. No illnesses, injuries, or specific safety hazards are reported in the source text; the issue is regulatory non-compliance. The recall affects a large number of units but represents a precautionary action rather than a known harm scenario.
Plain-English summary
Medline Industries, LP is recalling multiple catheterization and angiography kit models because the 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing components have been rescinded. The recalled kits include over 80 distinct model numbers across a broad range of cardiac, interventional radiology, and vascular procedures, with approximately 160,883 units affected.
These kits were distributed nationwide throughout the United States. The specific lot numbers and UDI identifiers for each affected model are provided by the FDA to enable healthcare facilities to identify and isolate affected inventory.
Healthcare providers and facilities that have received these kits should take action to identify affected lots by model number and lot number. Consult the detailed list of model numbers and lot numbers provided by the FDA. Any questions regarding this recall should be directed to Medline Industries, LP.
The recalled product
- Product
- Medline Kits: 1) CATH LAB CDS, Model Number: CDS840228F; 2) IR PACK, Model Number: DYNDH2104; 3) CARDIAC CATH PACK-LF, Model Number: DYNJT2164M; 4) ANGIOGRAPHY TRAY, Model Number: DYNJT3078; 5) CATH PACK, Model Number: DYNJT4190; 6) ANGIO VASCULAR PACK, Model Number…
- Manufacturer
- Medline Industries, LP
- Affected units
- 160,883
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 (20)
- 1) CDS840228F
- UDI-DI: 10889942778546(each)
- 40889942778547(case)
- Lot Number: 25ALA420
- 2) CDS840228F
- Lot Number: 25CLA774
- 3) CDS840228F
- Lot Number: 24LLA038
- 4) DYNDH2104
- UDI-DI: 10198459273964(each)
- 40198459273965(case)
- Lot Number: 25DBR609
- 5) DYNJT2164M
- UDI-DI: 10198459003165(each)
- 40198459003166(case)
- Lot Number: 24JBT885
- 6) DYNJT3078
- UDI-DI: 10198459305146(each)
- 40198459305147(case)
- Lot Number: 25DBN722
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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