Swab and Swabstick Drug Products Recall Due to Manufacturing Test Validation Uncertainty
Busse Convenience kits containing swab and swabstick drug products manufactured by PDI are recalled due to uncertainty about manufacturing test method validation. No illnesses have been reported.
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 or injuries. The issue concerns uncertainty about manufacturing test method validation, making this a precautionary recall.
Plain-English summary
Busse Convenience kits contain swab and swabstick drug products manufactured by Professional Disposables International (PDI) that are subject to recall. These products are distributed nationwide.
The recall is due to uncertainty regarding the adequacy of the validation of test methods used to manufacture these drug products. No illnesses or injuries have been reported.
The recalled product
- Product
- SS 4.5MM Pellet Insertion Tray Catalog Number:B8128R1
- Manufacturer
- Busse Hospital Disposables, Inc.
- Category
- Drug
- Hazard
- Affected units
- 50
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: 2130197 UDI: 00849233001855
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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