Busse Convenience Kits Recalled Due to Inadequate Manufacturing Test Validation
Busse Hospital Disposables is recalling Convenience kits containing swab/swabstick drug products due to uncertainty about the validation of manufacturing test methods. The FDA classified this as a Class II recall.
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 device recall with no reported illnesses, injuries, or deaths. The hazard is uncertainty about manufacturing test method validation—a procedural quality concern rather than a confirmed product defect. Per the rubric, recalls with no reported health impact and theoretical hazards score as Moderate (2).
Plain-English summary
Busse Hospital Disposables, Inc. is recalling Busse Convenience kits that contain swab/swabstick drug products manufactured by Professional Disposables International (PDI). The affected kits have Catalog Number B1568 and were distributed nationwide. Lot numbers 2130338 and 2130562 are affected, with UDI 00849233005525.
The FDA issued this Class II recall due to uncertainty regarding whether the test methods used to manufacture the swab/swabstick drug products were adequately validated. Proper validation of manufacturing test methods is essential to ensure that products meet required safety and quality standards.
Those who have received these recalled products should contact Busse Hospital Disposables, Inc. for guidance on returns or replacement.
The recalled product
- Product
- Female SS 3.5MM Pellet Insertion Tray Catalog Number: B1568
- Manufacturer
- Busse Hospital Disposables, Inc.
- Category
- Medical Device — Swabs
- Hazard
- manufacturing-validation
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: 2130338 2130562 UDI: 00849233005525
Distribution
Distributed nationwide across the United States.
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