Medline Neurological Sponges Recalled for Potential Endotoxin Variability
Medline Industries is recalling 128 Major Pack Convenience Kits containing neurological sponges due to potential endotoxin variability that may cause adverse health events.
What this means for you
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves potential health risks requiring medical intervention, such as neurovascular adverse events and hypotension, which aligns with the 'Severe' criteria for significant injury reports or high-risk medical device defects.
Plain-English summary
Medline Industries, LP is recalling 128 units of Medline Convenience Kits, specifically the Major Pack (Catalog Number DYNJ81325A). The affected products were distributed nationwide in the United States. The specific lot number is 23HBB258, with UDI-DI 10195327270360 for individual units and 40195327270361 for cases.
The recall is due to the potential for unexpected variability in endotoxin levels within the neurological sponges included in the kits. Potentially elevated endotoxin levels may present health risks that could require medical intervention. Reported or potential adverse effects include neurovascular adverse events, febrile response, local transient inflammation, hypotension, or nausea.
Healthcare facilities and consumers should check their inventory for the specific catalog number and lot number listed above. If the product is found, it should be removed from use and returned to Medline Industries, LP in accordance with their recall instructions.
The recalled product
- Product
- Medline Convenience Kits: 1) MAJOR PACK, Catalog Number: DYNJ81325A
- Manufacturer
- Medline Industries, LP
- Affected units
- 128
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 (4)
- 1) DYNJ81325A
- UDI-DI: 10195327270360(each)
- 40195327270361(case)
- Lot Number: 23HBB258
Distribution
Distributed nationwide across the United States.
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