Cervical Tray Catalog 1089 Recalled for Manufacturing Test Method Validation
Busse Hospital Disposables, Inc. is recalling Cervical Tray Catalog 1089 convenience kits due to uncertainty regarding adequate validation of manufacturing test methods. No illnesses or injuries have been reported.
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 FDA Class II recall addresses manufacturing test method validation uncertainty with no reported illnesses, injuries, or confirmed hazards. Per the rubric, precautionary recalls without confirmed risks are classified as Moderate (2).
Plain-English summary
Busse Hospital Disposables, Inc. is recalling Cervical Tray Catalog 1089 convenience kits distributed nationwide. These kits contain swabs and swabsticks, some of which were manufactured by Professional Disposables International (PDI).
The reason for the recall is uncertainty about whether the manufacturing test methods were properly validated. This means the company cannot confirm that the testing procedures used to check the quality of the products were adequately verified and documented.
The recall affects products with lot numbers 2030899, 2130011, 2130214, 2130789, 2130798, 2130898, and 2131135, identified by UDI 00849233000414.
No illnesses or injuries have been reported. Healthcare facilities and consumers should stop using products from these lot numbers and contact the manufacturer for instructions on returns or replacements.
The recalled product
- Product
- Cervical Tray Catalog 1089
- Manufacturer
- Busse Hospital Disposables, Inc.
- Category
- Medical Device
- Hazard
- Affected units
- 80
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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