Surgical valve pack kits recalled after cannulas may not retain shape
Medline is recalling 828 VALVE PACK-LF kits because they contain lots of cannula products where the catheter may not retain its shape.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: Scored 5 because the FDA classified this recall as Class I, which the rubric assigns the Critical tier.
Plain-English summary
Medline VALVE PACK-LF kits, model numbers DYNJ0415366P and DYNJ0415366Q, are being recalled because the kits contain certain lots of cannula products where the catheter may not retain its shape.
The recall covers 828 units across several lots, including 24DMG366 for model DYNJ0415366P and 25EMD672 and 25GMD016 for model DYNJ0415366Q. The product was distributed in California. The FDA has classified the recall as Class I.
Facilities holding the listed kit and lot numbers should quarantine affected stock and follow Medline's instructions rather than using the cannula components.
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 — Surgical kit
- Affected units
- 828
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
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