Lumbar Tray with Swab Products Recalled Due to Manufacturing Validation Uncertainty
Busse Hospital Disposables is recalling Lumbar Tray units nationwide because test methods used during manufacturing could not be adequately validated. The recall affects swab/swabstick products used in medical procedures.
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 without any reported illnesses or injuries. The hazard involves uncertain validation of manufacturing test methods rather than a confirmed product failure, making this a precautionary recall that merits a Moderate severity rating.
Plain-English summary
Busse Hospital Disposables, Inc. is recalling its Lumbar Tray (Catalog 1091) nationwide. The product contains swab/swabstick drug products manufactured by Professional Disposables International (PDI). The recall involves 330 units across affected lot numbers 2030899, 2130011, 2130214, 2130789, 2130798, 2130898, and 2131135 (UDI: 00849233000247).
The recall was initiated due to uncertainty regarding the adequacy of the validation of test methods used to manufacture these products. The manufacturer cannot confirm that the test methods used to verify product specifications during manufacturing were properly validated. This validation gap means the manufacturer cannot assure that the affected swab/swabstick products meet required manufacturing and safety specifications.
The product has been distributed nationwide.
The recalled product
- Product
- Lumbar Tray Catalog 1091
- Manufacturer
- Busse Hospital Disposables, Inc.
- Hazard
- manufacturing-validation
- sterility-risk
Distribution
Distributed nationwide across the United States.
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