Medline Neurological Surgery Kits Recalled for Endotoxin Variability
Medline is recalling 234 neurological surgery kits nationwide due to potential endotoxin variability that may cause adverse health reactions.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product where potential health risks are described, but the source text does not explicitly state that injuries or illnesses have been reported, fitting the 'High' severity criteria.
Plain-English summary
Medline Industries, LP is recalling 234 units of various neurological convenience kits, including the MAJOR NEURO VCH, NEURO PACK-LF, CRANIOTOMY PACK, MAJOR NEURO PACK, NEURO, NEURO PACK, and NEURO ACD kits. The affected products were distributed nationwide in the United States.
The recall is being issued because the kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.
Healthcare providers and facilities should check their inventory for the specific catalog numbers and lot numbers listed in the recall notice. If the affected kits are found, they should be removed from use and returned to Medline Industries, LP according to the instructions provided in the official recall documentation.
The recalled product
- Product
- Medline Convenience Kits: 1) MAJOR NEURO VCH, Catalog Number: DYNJ39218I; 2) NEURO PACK-LF, Catalog Number: DYNJ41246F; 3) CRANIOTOMY PACK (CRSJE)227-LF, Catalog Number: DYNJ47487A; 4) MAJOR NEURO PACK, Catalog Number: DYNJ57233J; 5) NEURO, Catalog Number: DYNJ82388A…
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 234
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) DYNJ39218I
- UDI-DI: 10195327013042(each)
- 40195327013043(case)
- Lot Number: 22HMA400
- 2) DYNJ41246F
- UDI-DI: 10195327112011(each)
- 40195327112012(case)
- Lot Number: 23GBS783
- 3) DYNJ47487A
- UDI-DI: 10889942106240(each)
- 40889942106241(case)
- Lot Number: 22HMD080
- 4) DYNJ57233J
- UDI-DI: 10198459723025(each)
- 40198459723026(case)
- Lot Number: 26CMG313
- 5) DYNJ82388A
- UDI-DI: 10195327482749(each)
- 40195327482740(case)
- Lot Number: 25KMB622
Distribution
Distributed nationwide across the United States.
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