Medline Medical Convenience Kits Recalled Due to Potential Bacillus Contamination
Medline Industries, LP is recalling specific Medline medical convenience kits because they may contain BD PurPrep 26 mL contaminated with low levels of Bacillus species.
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 3/5 (High).
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 potential microbial contamination (Bacillus species) in a medical device/kit, which represents a high-risk pathogen hazard where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling certain Medline medical convenience kits that contain BD PurPrep 26 mL. These kits may be contaminated with low levels of Bacillus species.
The affected products include the following kits: - KIT PEDIATRIC OPEN HEART MOSES (SKU DYNJ910103B, Lot 25FBR237) - BASIC HEART CDS (SKU DYNJ910961A, Lots 25ABM761, 25BBD107, 25FBD534, 25FBL772)
These kits were distributed in the United States to CT, FL, KS, OH, OR, NY, MD, MT, VA, and MA.
Users should check their inventory for the specified SKUs and lot numbers and follow manufacturer instructions for returning or disposing of the affected kits.
The recalled product
- Product
- Medline medical convenience kits labeled as: 1) KIT PEDIATRIC OPEN HEART MOSES, Medline Kit SKU DYNJ910103B; 2) BASIC HEART CDS, Medline Kit SKU DYNJ910961A.
- Manufacturer
- Medline Industries, LP
- Affected units
- 155
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 (9)
- Medline Kit SKU DYNJ910103B
- UDI/DI 10198459346873 (each) 40198459346874 (case)
- Lot Number 25FBR237
- Medline Kit SKU DYNJ910961A
- UDI/DI 10198459213342 (each) 40198459213343 (case)
- Lot Number 25ABM761
- Lot Number 25BBD107
- Lot Number 25FBD534
- Lot Number 25FBL772.
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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