Busse Convenience Kits with Swabs Recalled Due to Manufacturing Validation Uncertainty
Busse Convenience kits containing swab/swabstick drug products are recalled due to uncertainty about whether test methods used to validate manufacturing were adequately validated. Distributed nationwide.
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 with no reported illnesses or injuries. The hazard involves manufacturing process validation uncertainty rather than a documented direct harm. Per the rubric, Class II recalls without hospitalization reports and with theoretical hazards warrant a Moderate severity score.
Plain-English summary
Busse Hospital Disposables, Inc. is recalling Busse Convenience kits that contain one or more swab/swabstick drug products manufactured by Professional Disposables International (PDI). These kits are distributed nationwide. Affected lot numbers are 2020741, 2120119, 2120342, and 2120630.
The recall is due to uncertainty regarding the adequacy of the validation of test methods used during manufacturing. The testing and validation processes used to ensure manufacturing quality may not have been properly validated, creating uncertainty about whether these products meet required quality standards.
Healthcare facilities and other users who have received these convenience kits should identify affected lot numbers by checking product packaging.
The recalled product
- Product
- Bone Marrow Biopsy Tray Catalog Number: 8917R1
- Manufacturer
- Busse Hospital Disposables, Inc.
- Category
- Medical Device
- Hazard
- validation-failure
- quality-control-failure
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: 2020741 2120119 2120119 2120342 2120630 UDI: 00849233002012
Distribution
Distributed nationwide across the United States.
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