Medline Neurological Surgery Kits Recalled for Endotoxin Variability
Medline Industries is recalling 4,013 neurological surgery 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 causing adverse events) where no specific injuries or illnesses have been reported yet, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Medline Industries, LP is recalling 4,013 units of various neurological surgery convenience kits, including anterior spine, craniotomy, and laminectomy packs. The affected products were distributed nationwide in the United States.
The recall was initiated 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 facilities and consumers should check their inventory for the specific catalog numbers and lot numbers listed in the official recall notice. If you have used these products and are experiencing symptoms such as fever, low blood pressure, or inflammation, contact your healthcare provider.
The recalled product
- Product
- Medline Convenience Kits: 1) ANTERIOR SPINE PACK, Catalog Number: DYNJT10197; 2) CRANIOTOMY #IMF 56646-LF, Catalog Number: DYNJVB91001; 3) CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348O; 4) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348P; 5) LAMINECTOMY PACK-LF…
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 4,013
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) DYNJT10197
- UDI-DI: 10198459778865(each)
- 40198459778866(case)
- Lot Number: 26GBA998
- 2) DYNJVB91001
- UDI-DI: 10193489801170(each)
- 40193489801171(case)
- Lot Number: 23HLA649
- 3) DYNJVB91001
- Lot Number: 23GLA935
- 4) DYNJVB91001
- Lot Number: 23GLA081
- 5) DYNJVB91001
- Lot Number: 23CLA457
- 6) DYNJVB91001
- Lot Number: 23BLA516
- 7) DYNJ0369348O
- UDI-DI: 10195327025892(each)
- 40195327025893(case)
- Lot Number: 22IBO169
Distribution
Distributed nationwide across the United States.
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