Universal Nerve Block Tray Recalled Due to Manufacturing Test Validation Uncertainty
Busse Hospital Disposables recalls Universal Nerve Block Trays and swab products manufactured by PDI due to uncertainty regarding manufacturing test method validation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 precautionary recall due to manufacturing test method validation concerns. The hazard is theoretical, based on manufacturing process uncertainty rather than a known contamination or defect.
Plain-English summary
Busse Hospital Disposables, Inc. is recalling Universal Nerve Block Trays (Catalog Number 9818) that contain swab and swabstick drug products manufactured by Professional Disposables International (PDI). Sixty units were distributed nationwide, with affected lot numbers 2030783, 2031093, 2130287, 2130412, 2130681, and 2131043.
The recall was initiated due to uncertainty regarding the adequacy of validation of the test methods used to manufacture the drug products.
Healthcare providers and facilities that have received these products should contact Busse Hospital Disposables, Inc. for instructions regarding this recall.
The recalled product
- Product
- Universal Nerve Block Tray Catalog Number: 9818
- Manufacturer
- Busse Hospital Disposables, Inc.
- Category
- Drug — Medical / Swabs
- Hazard
- Affected units
- 60
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 58 recalled by Busse Hospital Disposables, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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