Swab Products in Busse Convenience Kits Recalled for Manufacturing Validation Issues
Busse Convenience kits containing swab products are being recalled due to inadequate validation of manufacturing test methods.
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: Class II FDA recall with no reported injuries or illnesses. The hazard concerns manufacturing test method validation and is precautionary in nature rather than based on known harm.
Plain-English summary
Busse Hospital Disposables, Inc. is recalling Busse Convenience kits that contain swab and swabstick products manufactured by Professional Disposables International (PDI). The lot numbers involved are 2110128 and 2110279.
The recall was initiated due to uncertainty about the adequacy of the validation of the test methods used to manufacture the products within these kits. This raises concerns about whether the products meet appropriate manufacturing standards.
The affected kits were distributed nationwide. Approximately 60 units were involved in this recall.
Consumers and healthcare facilities with these kits should discontinue use and contact Busse Hospital Disposables, Inc. for instructions on return or disposal.
The recalled product
- Product
- SS 4.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1365R1
- Manufacturer
- Busse Hospital Disposables, Inc.
- Hazard
- manufacturing-validation
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: 2110128 2110279 UDI: 00849233004412
Distribution
Distributed nationwide across the United States.
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