Swab and Swabstick Drug Products Recalled for Inadequate Manufacturing Validation
Busse Convenience kits containing swab/swabstick drug products manufactured by Professional Disposables International (PDI) have been recalled due to uncertainty regarding 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: This is an FDA Class II recall of medical swab drug products with a manufacturing validation issue. No illnesses or injuries have been reported. The hazard is characterized by uncertainty in manufacturing test method validation, which represents a theoretical risk-of-harm in products used in healthcare settings, fitting the criteria for High severity.
Plain-English summary
Busse Convenience kits containing swab/swabstick drug products manufactured by Professional Disposables International (PDI) have been recalled. The recalled products bear Lot Numbers 2130419, 2130880, and 2131187, with UDI 00849233005655. Distribution is nationwide.
The recall is due to uncertainty regarding the adequacy of the validation of the test methods used to manufacture the drug products. This means the manufacturing processes may not have been validated sufficiently to ensure the reliability and quality of the products.
The recalling firm is Busse Hospital Disposables, Inc. A total of 96 units are affected by this recall.
The recalled product
- Product
- Universal Tray Catalog 1567
- Manufacturer
- Busse Hospital Disposables, Inc.
- Category
- Drug — Swabs/Swabsticks
- Affected units
- 96
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: 2130419 2130880 2131187 UDI: 00849233005655
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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