Medical swab insertion tray recalled due to manufacturing validation uncertainty
Busse Hospital Disposables recalls swab insertion trays due to uncertainty about manufacturing test method validation. The Class II recall affects products nationwide.
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 with no reported illnesses or injuries. The hazard is manufacturing validation uncertainty rather than a confirmed defect or named high-risk pathogen. No hospitalizations, structural defects, or injury reports are documented.
Plain-English summary
Busse Hospital Disposables is recalling the SS 3.5mm Pellet Insertion Tray with Gloves (Catalog Number B1352, Lot Number 2010298). The recall includes Busse Convenience kits containing swab and swabstick products manufactured by Professional Disposables International (PDI).
The products are being recalled due to uncertainty regarding the adequacy of validation of the test methods used in the manufacturing process. The manufacturer did not sufficiently verify that the manufacturing process controls and test methods are adequate to ensure product quality.
The affected products were distributed nationwide. This is an FDA Class II recall. Users should discontinue use of these products and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- SS 3.5Mm Pellet Insertion Tray with large Gloves Catalog Number: B1352
- Manufacturer
- Busse Hospital Disposables, Inc.
- 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: 2010298 UDI: 00849233004719
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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