Swab and Swabstick Drug Products Recalled Due to Validation Uncertainty
Busse Convenience kits with swab and swabstick drug products are being recalled because the validation of the test methods used during manufacturing is uncertain.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is validation uncertainty regarding manufacturing test methods, which is precautionary in nature rather than a confirmed hazard.
Plain-English summary
Busse Hospital Disposables, Inc. is recalling 120 units of Busse Convenience kits containing swab and swabstick drug products manufactured by Professional Disposables International (PDI). The affected lot numbers are 2110082, 2110174, 2110254, and 2110221.
The reason for the recall is uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products.
These products were distributed nationwide.
The recalled product
- Product
- "3.2MM Pellet Insertion Tray with Medium Gloves" Catalog Number: B1351
- Manufacturer
- Busse Hospital Disposables, Inc.
- Category
- Drug
- Hazard
- Affected units
- 120
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: 2110082 2110174 2110254 2110221 UDI: 00849233004733
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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