Busse Pellet Insertion Tray Kits Recalled for Manufacturing Validation Issues
Busse Hospital Disposables is recalling Pellet Insertion Tray Kits due to uncertainty about whether manufacturing test methods were adequately validated. No illnesses or injuries have been reported.
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 medical device recall with uncertainty regarding manufacturing test validation adequacy, creating a risk-of-harm situation. While no illnesses or injuries have been reported, the potential for undetected manufacturing defects due to inadequate validation methodology constitutes a High severity risk for medical devices.
Plain-English summary
Busse Hospital Disposables, Inc. is recalling Convenience Kits containing swab/swabstick products manufactured by Professional Disposables International (PDI). The manufacturer identified uncertainty regarding whether the test methods used to validate manufacturing were themselves adequately validated.
The affected product is the 4.5MM Pellet Insertion Tray with Medium Gloves (Catalog Number B1362, Lot Number 2110098, UDI 00849233004610). Approximately 30 units were distributed nationwide.
No illnesses or injuries have been reported related to this recall. Consumers who have received these products should discontinue use and contact Busse Hospital Disposables for instructions regarding return or replacement.
The recalled product
- Product
- 4.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1362
- Manufacturer
- Busse Hospital Disposables, Inc.
- Hazard
- Affected units
- 30
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: 2110098 UDI: 00849233004610
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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