Busse Hospital Swab Products Recalled for Manufacturing Validation Uncertainty
Busse Hospital Disposables is recalling swab and swabstick drug products due to uncertainty about whether manufacturing test methods were adequately validated. No illnesses or injuries have been reported.
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: FDA Class II classification establishes a baseline severity level. The hazard is based on manufacturing process validation uncertainty rather than confirmed contamination or defect. No illnesses or injuries reported. The theoretical nature of the risk aligns with precautionary recall classification.
Plain-English summary
Busse Hospital Disposables, Inc. is recalling swab and swabstick drug products manufactured by Professional Disposables International (PDI) that are sold in Busse Convenience kits. The recall is due to uncertainty regarding the adequacy of the validation of the test methods used during manufacturing.
The affected products were distributed nationwide and are identified by lot number 2010304. The U.S. Food and Drug Administration has classified this as a Class II recall.
Consumers with questions or who believe they may have received affected products should contact Busse Hospital Disposables, Inc. for further information.
The recalled product
- Product
- SS 3.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1354
- Manufacturer
- Busse Hospital Disposables, Inc.
- Category
- Medical Device
- Hazard
- Affected units
- 30
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 (1)
- Lot Numbers: 2010304 UDI: 00849233004641
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 58 recalled by Busse Hospital Disposables, Inc. 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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