Drug Swab Products Recalled for Manufacturing Validation Uncertainty
Busse Convenience kits containing swab/swabstick drug products made by PDI are being recalled due to uncertainty about validation testing adequacy in manufacturing. Users should discontinue use of affected lot numbers.
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 initiated due to manufacturing validation uncertainty with no reported illnesses or injuries. Per the rubric, recalls with theoretical hazards and no reported harm are classified as Moderate, consistent with voluntary precautionary recalls.
Plain-English summary
Busse Convenience kits containing swab/swabstick drug products, manufactured by Professional Disposables International (PDI), are subject to recall. The affected products have lot numbers 2031074, 2031227, 2130194, 2130535, and 2130783. The UDI for these products is 00849233016996.
The recall is due to uncertainty regarding the adequacy of validation of the test methods used to manufacture these drug products. This is a manufacturing quality issue related to the validation of testing procedures employed during production.
The products were distributed nationwide. Individuals and healthcare facilities using these products should cease use of any kits bearing the affected lot numbers.
The recalled product
- Product
- 3.2MM Pellet Insertion Tray Catalog Number: B7345R1
- Manufacturer
- Busse Hospital Disposables, Inc.
- Category
- Drug — Swabs/Swabsticks
- Hazard
- manufacturing-defect
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: 2031074 2031227 2130194 2130535 2130783 UDI: 00849233016996
Distribution
Distributed nationwide across the United States.
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