Medline PICC Tray Model DYNJ41648A regulatory clearance rescinded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the 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded by FDA.
What this means for you
Illness, injury, or structural failure has been reported. 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clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing included in this kit have been rescinded by the FDA.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
- Hazard
- regulatory-clearance-rescission
- invalid-regulatory-status
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.