Swab Drug Products Recalled for Manufacturing Test Method Validation Uncertainty
Busse Convenience kits containing swab/swabstick drug products manufactured by Professional Disposables International (PDI) are being recalled due to uncertainty about the adequacy of test method validation used in manufacturing.
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 recall with no reported illnesses, injuries, or hospitalizations. The hazard is manufacturing process validation uncertainty rather than confirmed contamination or documented harm, making this a precautionary recall.
Plain-English summary
Busse Convenience kits contain one or more swab/swabstick drug products manufactured by Professional Disposables International (PDI) that are subject to recall. The recall was issued because of uncertainty regarding the adequacy of the validation of the test methods used to manufacture these drug products.
Manufacturing processes must be validated through appropriate testing to ensure product consistency and safety. When test method validation is uncertain or inadequate, there is a risk that products may not meet intended specifications or safety requirements.
The recalled products have been distributed nationwide (Lot Number 2131254, UDI 00849233003668). Consumers who have these products should stop using them and contact their healthcare provider or the manufacturer for guidance. Healthcare facilities and product distributors should verify whether they have received affected products and take appropriate action.
The recalled product
- Product
- Epidural Tray Catalog 1307
- Manufacturer
- Busse Hospital Disposables, Inc.
- Category
- Drug — Topical / Swab Products
- Affected units
- 64
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: 2131254 UDI: 00849233003668
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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