Medline angiography and catheter kits subject to rescinded regulatory clearances
Medline Industries is recalling 12 types of angiography and catheter kits because their 510(k) regulatory clearances have been rescinded. The kits were 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall involving medical devices used in invasive cardiovascular procedures. Rescission of 510(k) clearance indicates the devices may pose a significant risk because they lack valid regulatory authorization, and these are high-risk devices used in angiography and catheterization procedures.
Plain-English summary
Medline Industries, LP is recalling multiple angiography and catheter kits sold under various model numbers including ANGIOGRAPHY PACK-LF, ANGIO PACK, ANGIOGRAPHY PACK II, CATH ANGIO PACK, ANGIOGRAPHIC PACK, ANGIO TRAY W/CHLORAPREP, CEREBRAL ANGIOGRAM, and CSU CATH MANIFOLD KIT. A total of 3,183 units have been recalled.
The reason for this recall is that the 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing contained in these kits have been rescinded. This means the devices no longer have valid FDA clearance for marketing and distribution in the United States.
These kits were distributed nationwide. Healthcare facilities and other entities in possession of these kits should discontinue use and contact Medline Industries for instructions on how to proceed.
The recalled product
- Product
- Medline Kits: 1) ANGIOGRAPHY PACK-LF, Model Number: DYNJQ0505M; 2) ANGIO PACK, Model Number: DYNJT2021G; 3) ANGIOGRAPHY PACK, Model Number: DYNJ31377B; 4) ANGIO PACK, Model Number: DYNJ51279; 5) ANGIOGRAPHY PACK II, Model Number: DYNJ52447; 6) CATH ANGIO PACK, Model…
- Manufacturer
- Medline Industries, LP
- Affected units
- 3,183
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) DYNJQ0505M
- UDI-DI: 10889942846900(each)
- 40889942846901(case)
- Lot Number: 23KBL880
- 2) DYNJQ0505M
- Lot Number: 24ABA125
- 3) DYNJQ0505M
- Lot Number: 23IBA898
- 4) DYNJT2021G
- UDI-DI: 10193489608816(each)
- 40193489608817(case)
- Lot Number: 24CMH245
- 5) DYNJ31377B
- UDI-DI: 10889942106691(each)
- 40889942106692(case)
- Lot Number: 25LBQ639
- 6) DYNJ31377B
- Lot Number: 25GBF384
- 7) DYNJ51279
- UDI-DI: 10889942145300(each)
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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