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.
What this means for you
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
- Hazard
- inadequate-validation
- manufacturing-quality
Distribution
Distributed nationwide across the United States.
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