Medical Swabs Recalled Due to Manufacturing Test Method Validation Uncertainty
Busse Convenience kits containing medical swabs and sticks have been recalled due to uncertainty about whether the manufacturing test methods used 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: FDA Class II recall involving manufacturing test method validation uncertainty with no reported illnesses or injuries. The precautionary nature and lack of confirmed product defects support a Moderate severity rating.
Plain-English summary
Busse Convenience kits containing one or more swab and swabstick products are being recalled. The product is Port Tray Catalog 7607, identified by lot numbers 2010357, 2110129, 2110181, 2110225, and 2110252 (UDI: 00849233014176). 576 units of this product were distributed nationwide.
The swab and swabstick products were manufactured by Professional Disposables International (PDI). The recall was initiated due to uncertainty regarding the adequacy of the test methods used to validate the manufacturing process. The issue concerns manufacturing validation itself, not a confirmed defect in the products.
The recalled product
- Product
- Port Tray Catalog 7607
- Manufacturer
- Busse Hospital Disposables, Inc.
- Category
- Medical Device — Swabs
- Hazard
- Affected units
- 576
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: 2010357 2110129 2110181 2110225 2110252 UDI: 00849233014176
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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