Swab Products in Busse Convenience Kits Recalled for Manufacturing Validation Issues
Busse Convenience kits containing swab products are being recalled due to inadequate validation of manufacturing test methods.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: Class II FDA recall with no reported injuries or illnesses. The hazard concerns manufacturing test method validation and is precautionary in nature rather than based on known harm.
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 lot numbers involved are 2110128 and 2110279.
The recall was initiated due to uncertainty about the adequacy of the validation of the test methods used to manufacture the products within these kits. This raises concerns about whether the products meet appropriate manufacturing standards.
The affected kits were distributed nationwide. Approximately 60 units were involved in this recall.
Consumers and healthcare facilities with these kits should discontinue use and contact Busse Hospital Disposables, Inc. for instructions on return or disposal.
The recalled product
- Product
- SS 4.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1365R1
- Manufacturer
- Busse Hospital Disposables, Inc.
- 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: 2110128 2110279 UDI: 00849233004412
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
Similar recalls
- ModerateMedical Device Swabs Recalled Due to Manufacturing Validation Uncertainty
FDA (Devices) · 2022-05-25
- ModerateBusse recalls surgical instrument trays containing recalled gloves
FDA (Devices) · 2016-12-28
- ModerateBusse Breast Pack Surgical Instrument Tray Recalled for Labeling Update
FDA (Devices) · 2016-12-28
- HighMedline Convenience Kits Recalled Due to Weak Breather Pouch Seals
FDA (Devices) · 2025-04-23
- HighMedline Intubation Tray Convenience Kits Recalled for Weak Breather Pouch Seals
FDA (Devices) · 2025-04-23
- ModerateBusse Lumbar Puncture Tray Recalled for Foreign Matter
FDA (Devices) · 2018-02-14