Convenience Kits with Drug Swab Products Recalled for Validation Uncertainty
Busse Convenience kits containing swab/swabstick drug products are being recalled nationwide due to uncertainty about the adequacy of the validation of manufacturing test methods.
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: This is an FDA Class II recall with validation methodology concerns but no reported illnesses or injuries. The hazard is theoretical—uncertainty about test method validation rather than confirmed product defect—resulting in a Moderate severity rating per rubric guidance for precautionary recalls.
Plain-English summary
Busse Convenience kits containing swab/swabstick drug products manufactured by Professional Disposables International (PDI) are being recalled. The recall is due to uncertainty regarding the adequacy of the validation of the test methods used to manufacture these drug products.
The recall affects units distributed nationwide, including Lot Number 2130324 (UDI: 00849233005556). The recall involves 48 units in total. Busse Hospital Disposables, Inc. is the firm issuing the recall.
The recalled product
- Product
- Male SS 4.5MM Pellet Insertion Tray Catalog Number: B1570
- Manufacturer
- Busse Hospital Disposables, Inc.
- Hazard
- Affected units
- 48
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: 2130324 UDI: 00849233005556
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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