Medline Catheter Valve Kits Recalled for Shape-Retention Defect
Medline is recalling 828 units of VALVE PACK-LF catheter kits because the catheter may not retain its shape, potentially causing device malfunction.
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: FDA classified this as Class I, which mandates a minimum severity score of 4 per the recall rubric. A defect where a catheter may not retain its shape poses a risk of device malfunction during clinical use.
Plain-English summary
Medline Industries is recalling certain lots of VALVE PACK-LF catheter kits (Models DYNJ0415366P and DYNJ0415366Q) because the catheter may not retain its shape during use. A total of 828 units have been distributed nationwide in California.
The recall affects multiple lot numbers across both model variations, including lots 24DMG366, 25EMD672, 25GMD016, 25AMB610, 25BMJ241, 25CMI425, 24DMC189, 24EMC463, 24GMJ353, 24IMB824, and 24KME116.
This defect could compromise the catheter's function if it does not maintain its shape during clinical use.
The recalled product
- Product
- Medline Kits: 1) VALVE PACK-LF, Model Number: DYNJ0415366P; 2) VALVE PACK-LF, Model Number: DYNJ0415366Q
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device
- Hazard
- device-malfunction
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) DYNJ0415366P
- UDI-DI: 10195327177966(each)
- 40195327177967(case)
- Lot Number: 24DMG366
- 2) DYNJ0415366Q
- UDI-DI: 10195327678227(each)
- 40195327678228(case)
- Lot Number: 25EMD672
- 3) DYNJ0415366Q
- Lot Number: 25GMD016
- 4) DYNJ0415366Q
- Lot Number: 25AMB610
- 5) DYNJ0415366Q
- Lot Number: 25BMJ241
- 6) DYNJ0415366Q
- Lot Number: 25CMI425
- 7) DYNJ0415366Q
- Lot Number: 24DMC189
- 8) DYNJ0415366Q
- Lot Number: 24EMC463
Distribution
Distributed nationwide across the United States.
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