FDA Recalls Swab Products for Manufacturing Validation Uncertainty
Busse Convenience kits containing swab/swabstick products from Professional Disposables International have been recalled by the FDA due to uncertainty about adequate 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 no reported illnesses or injuries. The recall addresses manufacturing test method validation uncertainty, a quality-control issue rather than a specific identified hazard.
Plain-English summary
The FDA has recalled Busse Convenience kits containing swab/swabstick products manufactured by Professional Disposables International (PDI). The affected products are identified by lot numbers 2110054 and 2110116, with UDI 00849233005365, with 60 units distributed nationwide.
The recall was initiated due to uncertainty regarding the adequacy of validation of the test methods used to manufacture these products. This represents a quality-control concern about whether the manufacturing process was properly validated according to FDA standards.
Healthcare facilities and users of these products should contact Busse Hospital Disposables, Inc., the recalling firm, for information regarding return or disposal of affected units.
The recalled product
- Product
- SS 3.5MM Diamond Tip Trocar - Large Gloves Catalog Number: B1547
- Manufacturer
- Busse Hospital Disposables, Inc.
- Category
- Medical Device
- Hazard
- Affected units
- 60
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: 2110054 2110116 UDI: 00849233005365
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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