Busse Hospital Swab Products Recalled for Manufacturing Validation Uncertainty
Busse Hospital Disposables is recalling Busse Convenience kits containing swab products due to uncertainty about manufacturing test method validation. No illnesses or injuries have been reported.
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: FDA Class II recall initiated due to uncertain manufacturing test method validation, with no reported illnesses or injuries. This is a precautionary quality-assurance recall rather than a direct safety hazard.
Plain-English summary
Busse Hospital Disposables, Inc. is recalling Busse Convenience kits that contain swab and swabstick products manufactured by Professional Disposables International (PDI). The recall affects 60 units distributed nationwide.
The recall was initiated due to uncertainty about the adequacy of the validation of the test methods used to manufacture these products. This represents a precautionary measure regarding manufacturing process validation.
The affected lot numbers are 2130220, 2130445, and 2131063 (UDI: 00849233000179). Consumers or healthcare facilities that have received these products should contact Busse Hospital Disposables, Inc. for further instructions.
The recalled product
- Product
- MBB Tray Catalog Number: 9882
- Manufacturer
- Busse Hospital Disposables, Inc.
- Hazard
- manufacturing-validation-failure
- quality-control-issue
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: Lot 2130220 2130445 2131063 UDI: 00849233000179
Distribution
Distributed nationwide across the United States.
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