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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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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