Pump Refill Kit Recalled Over Uncertain Manufacturing Test Method Validation
Busse Hospital Disposables is recalling Pump Refill Kits nationwide due to uncertainty about whether manufacturing test methods were properly validated. The recall affects 40 units.
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 uncertainty about manufacturing test method validation. The hazard is theoretical rather than a confirmed safety defect, characterizing this as a precautionary manufacturing quality recall.
Plain-English summary
Busse Hospital Disposables, Inc. is recalling Pump Refill Kit with Catalog Number 7347R1 that was distributed nationwide. The product contains swab/swabstick drug products manufactured by Professional Disposables International (PDI).
The recall was issued because of uncertainty regarding the adequacy of the validation of test methods used to manufacture the drug products. This means the manufacturer cannot confirm that the test methods used during production were properly validated.
The recalled product was distributed nationwide. The recall includes 40 units with Lot Numbers 2030921 and 2130507, and UDI 00849233009363.
Consumers and healthcare facilities in possession of these products should stop using them and contact Busse Hospital Disposables, Inc. or the FDA for guidance on return and replacement options.
The recalled product
- Product
- Pump Refill Kit Catalog Number: 7347R1
- Manufacturer
- Busse Hospital Disposables, Inc.
- Category
- Medical Device
- 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: 2030921 2130507 UDI: 00849233009363
Distribution
Distributed nationwide across the United States.
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