Busse swab and swabstick products recalled for validation uncertainty
Busse Convenience kits containing swab and swabstick drug products are recalled nationwide due to uncertainty about whether manufacturing test methods were adequately validated.
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 recall where no illnesses or injuries have been reported and the hazard is a process/validation uncertainty rather than confirmed contamination or defect, fitting the criteria for a voluntary precautionary recall.
Plain-English summary
Busse Hospital Disposables, Inc. is recalling Busse Convenience kits that contain swab and swabstick drug products manufactured by Professional Disposables International (PDI). The affected recall includes 120 units distributed nationwide.
The recall is due to uncertainty regarding the adequacy of the validation of the test methods used to manufacture these drug products. This validation uncertainty raised concerns about whether manufacturing processes were properly validated to ensure product safety and performance.
The affected products are identified by Lot Numbers 2010270, 2110081, 2110173, 2110220, and UDI 00849233003835. If you possess these products, discontinue use and contact Busse Hospital Disposables for further information and instructions.
The recalled product
- Product
- 3.2MM Pellet Insertion Tray Catalog Number: B1144
- Manufacturer
- Busse Hospital Disposables, Inc.
- Category
- Drug — Swabs and Swabsticks
- Hazard
- Affected units
- 120
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: 2010270 2110081 2110173 2110220 UDI: 00849233003835
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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