Swab drug products recalled due to inadequate test method validation
Busse Hospital Disposables is recalling convenience kits containing swab drug products manufactured by Professional Disposables International due to uncertainty about the adequacy of test methods used in manufacturing.
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 for drug-delivery swab products with unvalidated manufacturing test methods. No illnesses, injuries, or deaths reported. This qualifies as a risk-of-harm product where injury has not yet been reported, per severity rubric.
Plain-English summary
Busse Hospital Disposables is recalling convenience kits containing swab or swabstick drug products manufactured by Professional Disposables International (PDI). Approximately 1040 units were distributed nationwide. The affected lot numbers are 2030875, 2030980, 2031048, 2031096, 2130563, and 2130722.
The recall was initiated due to uncertainty regarding the adequacy of the validation of the test methods used to manufacture the drug products. This means the manufacturing processes and quality assurance procedures may not have been properly validated to ensure the products meet established standards for safety and effectiveness.
Customers who have received these convenience kits should discontinue use and contact Busse Hospital Disposables for further instructions on handling and replacement of the affected products.
The recalled product
- Product
- Female SS 3.5MM Pellet Insertion Tray Catalog Number: B9175R1
- Manufacturer
- Busse Hospital Disposables, Inc.
- Category
- Drug — Swabs
- Hazard
- inadequate-validation
Distribution
Distributed nationwide across the United States.
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