Busse Convenience Kits Recalled Due to Manufacturing Test Validation Uncertainty
Busse Convenience kits containing swab/swabstick drug products from Professional Disposables International are being recalled due to uncertainty about test method validation during manufacturing. The affected products include lot numbers 2110053 and 2110115, representing 60 units distributed 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: FDA Class II classification indicates potential for adverse health consequences, but this is a precautionary manufacturing process validation recall rather than a known product contamination or defect. The specific hazard is undefined, fitting the Moderate category for voluntary precautionary recalls.
Plain-English summary
Busse Hospital Disposables, Inc. is recalling Busse Convenience kits containing swab/swabstick drug products manufactured by Professional Disposables International (PDI). The recall was initiated due to uncertainty about the adequacy of test method validation procedures used during manufacturing.
The affected kits are identified by lot numbers 2110053 and 2110115. A total of 60 units of these products were distributed nationwide.
The recalled product
- Product
- SS 3.5MM Diamond Tip Trocar - Medium Gloves Catalog Number: B1555
- Manufacturer
- Busse Hospital Disposables, Inc.
- Category
- Drug
- Hazard
- Affected units
- 60
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: Lot 2110053 2110115 UDI: 00849233005402
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 · manufacturing validation
See all →- HighNorepinephrine IV bags recalled for sterility validation deficiency
FDA (Drugs) · 2023-08-09
- ModerateMedical Swabs Recalled Due to Manufacturing Test Method Validation Uncertainty
FDA (Devices) · 2022-06-08
- ModerateSwab and Swabstick Drug Products Recall Due to Manufacturing Test Validation Uncertainty
FDA (Devices) · 2022-06-08
- ModerateUniversal Nerve Block Tray Recalled Due to Manufacturing Test Validation Uncertainty
FDA (Devices) · 2022-06-08
- HighBusse Convenience Kits With Swab Products Recalled for Manufacturing Validation Issues
FDA (Devices) · 2022-06-08