Busse Convenience Kits Recalled: Drug Swabs Face Manufacturing Validation Uncertainty
Professional Disposables International's swab and swabstick drug products, sold in Busse Convenience kits, are recalled due to uncertainty about whether manufacturing validation test methods were adequate.
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: Class II FDA recall with no reported illnesses or injuries. The hazard is a theoretical manufacturing validation concern rather than a known active danger. Meets criteria for High severity as a risk-of-harm product before injury has been reported.
Plain-English summary
Busse Convenience kits contain swab and swabstick drug products manufactured by Professional Disposables International (PDI). These products are being recalled due to uncertainty about the adequacy of the validation test methods used during manufacturing.
The concern is that the manufacturing process may not have been properly validated, meaning the products might not meet required specifications or quality standards. Parties in possession of these kits should contact Busse Hospital Disposables for further information and instructions.
The recalled product
- Product
- Nerve Block Tray Catalog Number: 6796R3
- Manufacturer
- Busse Hospital Disposables, Inc.
- Category
- Drug
- Affected units
- 200
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: 2031026 2031218 2130212 2130896 UDI: 00849233015944
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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