Busse Convenience Kits Swabs Recalled Due to Testing Validation Uncertainty
Busse Hospital Disposables is recalling Busse Convenience Kits containing medical swabs and swabsticks due to uncertainty about test method validation in manufacturing. No illnesses 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: FDA Class II recall with no reported illnesses or injuries. The hazard is theoretical, based on uncertainty of manufacturing test method validation rather than a documented product defect. Per the rubric, with no reported harm and a theoretical hazard, the maximum score is 3; this precautionary manufacturing quality recall is classified as Moderate (2).
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 recall is being conducted due to uncertainty regarding the adequacy of validation of the test methods used to manufacture these products.
The recall affects 421 units distributed nationwide. Affected lot numbers are 2031092, 2130020, 2130288, 2130670, 2130905, 2131181, and 2131317 (UDI: 00849233012158).
No illnesses or injuries have been reported. Patients, healthcare facilities, and consumers who possess these products should discontinue use and contact Busse Hospital Disposables for information regarding product returns or replacements.
The recalled product
- Product
- Pain Tray Catalog Number: 9883
- Manufacturer
- Busse Hospital Disposables, Inc.
- Hazard
- Affected units
- 421
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.
See all 58 products in this recall →Related recalls
Same manufacturer · Busse Hospital Disposables, Inc.
See all →- SevereDressing change tray recalled for sterility assurance failure
FDA (Devices) · 2024-01-10
- SevereTracheostomy care kits recalled for sterility assurance failure
FDA (Devices) · 2024-01-10
- SevereTracheostomy care sets recalled for sterility assurance failure
FDA (Devices) · 2024-01-10
- ModerateSurgical Injection Tray Recalled Due to Adhesive Liner Defect
FDA (Devices) · 2022-12-07
- Moderate3M Steri-Drape Surgical Drapes Recalled Due to Adhesive Liner Defect
FDA (Devices) · 2022-12-07
Same hazard · inadequate testing
See all →- HighBaxter SIGMA Spectrum Infusion Pump recall due to inadequate pre-release testing
FDA (Devices) · 2024-08-14
- HighMedtronic Cobalt XT DR MRI cardioverter defibrillator battery testing defect
FDA (Devices) · 2024-01-31
- HighBusse Convenience Kits Recalled Due to Manufacturing Test Validation Issue
FDA (Devices) · 2022-06-08
- HighCore Biopsy Tray Recall Due to Manufacturing Validation Uncertainty
FDA (Devices) · 2022-06-08
- ModerateBusse Hospital Epidural Trays Recalled for Manufacturing Validation Uncertainty
FDA (Devices) · 2022-06-08