Medline PICC Tray Model DYNJ41648A regulatory clearance rescinded
Medline Industries has recalled its PICC Tray (Model DYNJ41648A) because the 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded by FDA.
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: The agency classified this as a Class II recall, and the rescission of 510(k) regulatory clearances for medical device components indicates the product lacks valid regulatory authority to remain in distribution. This meets the criterion for Severe (Class II with risk-of-harm context).
Plain-English summary
Medline Industries, LP is recalling the PICC Tray, Model Number DYNJ41648A, nationwide. The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing included in this kit have been rescinded by the FDA.
The affected product is distributed nationwide in the United States. Users of this device should discontinue use and contact Medline Industries for further instructions regarding the recalled kits.
No further details regarding specific adverse events or additional distribution information were provided in the recall notice.
The recalled product
- Product
- Medline Kits: 1) PICC TRAY, Model Number: DYNJ41648A
- Manufacturer
- Medline Industries, LP
- Affected units
- 20
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 (6)
- 1) DYNJ41648A
- UDI-DI: 10198459062834(each)
- 40198459062835(case)
- Lot Number: 25CLA242
- 2) DYNJ41648A
- Lot Number: 24LLA758
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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