Busse Convenience Kits Recalled Due to Manufacturing Test Validation Issue
Busse Hospital Disposables is recalling Busse Convenience kits containing swab/swabstick drug products due to uncertainty about the adequacy of manufacturing test method validation.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II designation indicates regulatory concern beyond minor defects. The issue involves uncertainty about the adequacy of manufacturing test method validation for drug products, representing a potential risk of harm. No illnesses or injuries have been reported.
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 affects 300 units distributed nationwide.
The affected product lot numbers are 2030982, 2031072, 2130198, 2130352, 2130706, and 2130876 (UDI: 00849233002227).
The recall was issued due to uncertainty regarding the adequacy of the validation of the test methods used to manufacture the drug products. This raises concerns that the manufacturing test methods may not have been sufficiently validated to ensure product quality and safety.
The recalled product
- Product
- SS 3.2MM Pellet Insertion Tray Catalog Number: B8110R1
- Manufacturer
- Busse Hospital Disposables, Inc.
- Category
- Drug
- Hazard
- Affected units
- 300
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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