Cervical Tray Recalled for Manufacturing Test Method Validation Uncertainty
Busse Hospital Disposables is recalling Cervical Tray Catalog Number 3765R2 units containing swab products due to uncertainty about the adequacy of manufacturing test method validation. Lot Numbers 2031213S and 2130221S are affected.
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 test method validation uncertainty rather than a confirmed safety defect. No reported illnesses, injuries, or actual harm are mentioned in the source material. Per the rubric, precautionary recalls without reported harm are classified as Moderate (2).
Plain-English summary
Busse Hospital Disposables, Inc. is recalling Cervical Tray Catalog Number 3765R2 units that contain swab/swabstick products manufactured by Professional Disposables International. The affected products bear Lot Numbers 2031213S and 2130221S, with 40 units distributed nationwide.
The recall was initiated due to uncertainty regarding the adequacy of the validation of the test methods used to manufacture the swab/swabstick products. The company could not confirm that the test methods were sufficiently validated.
This is a Class II FDA medical device recall. Individuals or healthcare facilities in possession of these products should contact Busse Hospital Disposables, Inc. for instructions regarding the recall.
The recalled product
- Product
- Cervical Tray Catalog Number: 3765R2
- Manufacturer
- Busse Hospital Disposables, Inc.
- Category
- Medical Device — Surgical
- Hazard
- test-method-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: 2031213S 2130221S UDI: 00849233015203
Distribution
Distributed nationwide across the United States.
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