Busse Convenience Kits Recalled Due to Manufacturing Test Validation Uncertainty
Busse Hospital Disposables is recalling convenience kits containing swab and swabstick products due to uncertainty regarding the adequacy of manufacturing test method validation. Affected lot numbers are 2110127 and 2110269.
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 a Class II FDA medical device recall with no reported illnesses or injuries. The hazard is manufacturing test validation uncertainty rather than a confirmed defect. Per the severity rubric, it qualifies as a risk-of-harm product where injury has not been reported, meeting the criteria for High severity.
Plain-English summary
Busse Hospital Disposables, Inc. is recalling Busse Convenience kits that contain swab and swabstick products manufactured by Professional Disposables International (PDI). The recalled products are distributed nationwide. Affected lot numbers are 2110127 and 2110269, representing 60 units.
The U.S. Food and Drug Administration (FDA) issued this Class II recall due to uncertainty regarding the adequacy of the validation of the test methods used to manufacture the drug products. The specific nature of the manufacturing validation deficiency has not been detailed in the recall notice.
The recalled product
- Product
- SS 4.5MM Pellet Insertion Tray with Large Gloves Catalog Number: B1363R1
- Manufacturer
- Busse Hospital Disposables, Inc.
- Affected units
- 60
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: 2110127 2110269 UDI: 00849233006515
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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