Swab and Swabstick Drug Products Recalled for Manufacturing Validation Uncertainty
Busse Convenience kits containing swab/swabstick drug products manufactured by Professional Disposables International are being recalled due to uncertainty about 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 recall of drug products where manufacturing test method validation is uncertain. This qualifies as a risk-of-harm product without reported injuries, meeting the High severity criterion.
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 involves 480 units distributed nationwide, with affected lot numbers 2031105, 2130068, 2130167, 2130508, 2130862, and 2131115.
The recall was issued due to uncertainty regarding the adequacy of the validation of the test methods used to manufacture these drug products. This means the company cannot confirm that the manufacturing process validation was sufficient to ensure the products are safe and meet required standards.
The recalled product
- Product
- Joint Injection Tray Catalog Number: 8561R1
- Manufacturer
- Busse Hospital Disposables, Inc.
- Category
- Drug — Swabs
- Affected units
- 480
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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