Swab and Swabstick Drug Products Recalled Due to Manufacturing Validation Defects
Busse Hospital Disposables is recalling convenience kits containing swab and swabstick drug products due to uncertainty about the adequacy of manufacturing test method validation. Products were distributed nationwide.
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: FDA Class II recall initiated due to manufacturing validation uncertainty with no reported illnesses or injuries. The recall is precautionary in nature, focused on process validation rather than a confirmed product defect.
Plain-English summary
Busse Hospital Disposables, Inc. is recalling 30 units of 4.5MM Pellet Insertion Trays with Large Gloves (catalog number B1360, lot 2010336) that contain swab and swabstick drug products manufactured by Professional Disposables International (PDI). These products were distributed nationwide.
The recall was initiated due to uncertainty regarding the adequacy of the validation of test methods used in manufacturing the drug products. Without proper validation of manufacturing test methods, there is uncertainty about whether the products meet required manufacturing and quality standards.
The recalled product
- Product
- 4.5MM Pellet Insertion Tray with Large Gloves Catalog Number: B1360
- Manufacturer
- Busse Hospital Disposables, Inc.
- Category
- Drug
- Affected units
- 30
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: 2010336 UDI: 00849233004627
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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