Universal Nerve Block Tray swab products recalled for manufacturing test validation concerns
Busse Hospital Disposables is recalling Universal Nerve Block Tray units (catalog 9779) due to uncertainty regarding test method validation in manufacturing the included swab/swabstick drug products. 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: This is an FDA Class II precautionary recall with no reported illnesses or injuries. The hazard involves uncertainty about test method validation used in manufacturing—a process validation issue rather than a confirmed product defect or contamination.
Plain-English summary
Busse Hospital Disposables, Inc. is recalling the Universal Nerve Block Tray (catalog number 9779) due to concerns about the adequacy of test method validation used to manufacture the swab/swabstick drug products contained within these kits. The swab products were manufactured by Professional Disposables International (PDI).
The recalled product has nationwide distribution. Affected units include lot numbers 2031030, 2130009, 2130328, 2130645, with a total of 400 units identified. The UDI (unique device identifier) is 00849233012134.
The recall is precautionary and stems from uncertainty regarding whether the test methods used to validate and ensure the drug products meet specifications were themselves adequately validated. No illnesses or injuries have been reported in connection with this product.
The recalled product
- Product
- Universal Nerve Block Tray Catalog Number: 9779
- Manufacturer
- Busse Hospital Disposables, Inc.
- Category
- Drug
- 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: 2031030 2130009 2130328 2130645 UDI: 00849233012134
Distribution
Distributed nationwide across the United States.
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