Nerve Block Tray Recalled Due to Manufacturing Validation Uncertainty
Busse Hospital Disposables recalled Nerve Block Tray units (catalog #8415) containing swab components due to uncertainty about adequate test method validation. The recall affects 420 units distributed nationwide.
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 FDA Class II medical device recall addresses manufacturing validation uncertainty in components used in anesthesia procedures. The hazard is a manufacturing quality control issue (test method validation) that represents a potential risk of harm. This meets the rubric criterion for Score 3 (High): a risk-of-harm product in the absence of explicitly reported injuries.
Plain-English summary
Busse Hospital Disposables, Inc. is recalling Nerve Block Tray (Catalog Number 8415) units. The kits contain swab and swabstick drug products manufactured by Professional Disposables International (PDI). According to the FDA, the recall is due to uncertainty regarding the adequacy of the validation of test methods used during manufacturing of these components.
The recall affects 420 units that were distributed nationwide, including lot numbers 2030832, 2031190, 2130252, 2130629, 2130742, 2131125, and 2131223.
Healthcare facilities that received affected units should stop using them and contact Busse Hospital Disposables, Inc. for guidance on return or replacement.
The recalled product
- Product
- Nerve Block Tray Catalog Number: 8415
- Manufacturer
- Busse Hospital Disposables, Inc.
- Affected units
- 420
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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