Medline Medical Convenience Kits Recalled Due to Potential Bacillus Contamination
Medline Industries, LP is recalling specific Medline NEURO PACK convenience kits because they may contain low levels of Bacillus species contamination.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which involves a remote possibility of adverse health consequences.
Plain-English summary
Medline Industries, LP is recalling specific Medline medical convenience kits labeled as NEURO PACK (SKU DYNJ59397P). These kits contain BD PurPrep 26 mL.
The recall was initiated because the product may be contaminated with low levels of Bacillus species.
This recall affects 574 kits distributed in CT, FL, KS, OH, OR, NY, MD, MT, VA, and MA. Affected lot numbers include 25AMJ225, 25CMF838, 24KME164, 25DMB248, 25FMD941, 25GMB662, and 25GMG296.
The recalled product
- Product
- Medline medical convenience kits labeled as: NEURO PACK, Medline Kit SKU DYNJ59397P
- Manufacturer
- Medline Industries, LP
- Hazard
- Affected units
- 574
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 (8)
- UDI/DI 10198459098109 (each) 40198459098100 (case)
- Lot Numbers: 25AMJ225
- 25CMF838
- 24KME164
- 25DMB248
- 25FMD941
- 25GMB662
- 25GMG296.
Distribution
Part of a larger recall action
This product is one of 4 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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