Procedural Accessory Kit Recalled for Manufacturing Validation Uncertainty
Busse Hospital Disposables is recalling Procedural Accessory Kits containing swabs due to uncertainty regarding the validation of manufacturing test methods. 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 precautionary recall based on manufacturing process validation uncertainty with no reported illnesses or injuries. The hazard is theoretical rather than an identified defect or contamination, placing this in the moderate category.
Plain-English summary
Busse Hospital Disposables, Inc. is recalling Procedural Accessory Kits (Catalog Number 9665R2, Lot 2031038) that contain swab and swabstick drug products manufactured by Professional Disposables International (PDI). The recall affects 250 units distributed nationwide.
The recall was initiated due to uncertainty about the adequacy of the validation of the test methods used to manufacture the products. The FDA classified this as a Class II recall. No illnesses or injuries have been reported in connection with this recall.
Healthcare facilities and users in possession of affected kits should discontinue use and contact Busse Hospital Disposables for return or replacement instructions. For additional information, contact the recalling firm or visit the FDA website using the recall number Z-1178-2022.
The recalled product
- Product
- Procedural Accessory Kit Catalog Number: 9665R2
- Manufacturer
- Busse Hospital Disposables, Inc.
- Hazard
- manufacturing-validation-uncertainty
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: 2031038 UDI: 00860000210461
Distribution
Distributed nationwide across the United States.
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