Procedure Tray Recalled for Manufacturing Test Method Validation Uncertainty
Busse Hospital Disposables is recalling Procedure Tray Catalog 1065 nationwide due to uncertain validation of manufacturing test methods for the swab/swabstick drug products inside.
What this means for you
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 hazard is manufacturing process validation uncertainty rather than a confirmed defect or contamination, making it a precautionary recall.
Plain-English summary
Busse Hospital Disposables, Inc. is recalling Procedure Tray Catalog 1065 nationwide. The product contains swab/swabstick drug products manufactured by Professional Disposables International (PDI). The recall involves 46 units distributed nationwide. Affected lot numbers are 2030699 and 2130342 (UDI: 00849233003354).
The reason for the recall is uncertainty regarding the adequacy of the validation of the test methods used to manufacture the drug products contained in the procedure trays.
The recalled product
- Product
- Procedure Tray Catalog 1065
- Manufacturer
- Busse Hospital Disposables, Inc.
- Category
- Drug
- Hazard
- Affected units
- 46
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: 2030699 2130342 UDI: 00849233003354
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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