Medline Craniotomy Kits Recalled for Potential Endotoxin Variability
Medline is recalling 486 craniotomy convenience kits 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 medical device with a risk of harm (endotoxin variability) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products without reported illness.
Plain-English summary
Medline Industries, LP is recalling 486 units of MFC and SLUH Craniotomy Packs. The recall covers specific catalog numbers and lot numbers distributed nationwide in the United States.
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 facilities and consumers should check their inventory for the specific catalog numbers and lot numbers listed in the recall notice. If the affected products are found, they should be removed from use and returned to Medline or the distributor.
The recalled product
- Product
- Medline Convenience Kits: 1) MFC CRANIOTOMY PACK, Catalog Number: DYNJT8784; 2) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348Q; 3) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348R; 4) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348S; 5) SLUH CRANIOTOMY…
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Kits
- Affected units
- 486
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) DYNJT8784
- UDI-DI: 10198459756368(each)
- 40198459756369(case)
- Lot Number: 26EBN238
- 2) DYNJ0369348Q
- UDI-DI: 10198459200632(each)
- 40198459200633(case)
- Lot Number: 25GBC553
- 3) DYNJ0369348Q
- Lot Number: 25FBA082
- 4) DYNJ0369348Q
- Lot Number: 25EBP462
- 5) DYNJ0369348Q
- Lot Number: 25DBU966
- 6) DYNJ0369348Q
- Lot Number: 25CBS315
- 7) DYNJ0369348R
- UDI-DI: 10198459442094(each)
- 40198459442095(case)
- Lot Number: 25JBB880
Distribution
Distributed nationwide across the United States.
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