Busse Convenience Kit Swab Products Recalled for Test Method Validation Issues
Busse Convenience kits containing swab and swabstick drug products manufactured by Professional Disposables International are being recalled due to uncertainty about test method validation during manufacturing.
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 recall with no reported illnesses or injuries. The hazard involves manufacturing process validation uncertainty rather than a confirmed product defect, making this a precautionary measure.
Plain-English summary
Busse Convenience kits containing swab and swabstick drug products are being recalled by Professional Disposables International due to uncertainty regarding the adequacy of the validation of test methods used in manufacturing these products.
The manufacturer identified that the methods used to test these products during manufacturing may not have been adequately validated to ensure product quality and safety. This is a precautionary measure to address manufacturing process concerns.
These products have been distributed nationwide. Users should discontinue use of the recalled products and contact their supplier or the manufacturer for guidance on replacement products.
No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- SS 4.5MM DIAMOND TIP TROCAR WITH MEDIUM GLOVES Catalog Number: B1560
- Manufacturer
- Busse Hospital Disposables, Inc.
- Category
- Drug
- 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: 2110059 UDI: 00849233005426
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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