Epidural Tray Recalled Due to Manufacturing Validation Uncertainty
Busse Hospital Disposables recalls approximately 425 units of its Single Shot Epidural Tray nationwide due to inadequate validation of manufacturing test methods for swab components.
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 an FDA Class II recall concerning a manufacturing test method validation defect in a sterile medical device used in high-risk epidural procedures. The validation uncertainty creates a risk-of-harm situation, meeting the rubric criterion for high-severity recalls involving risk-of-harm where injury has not yet been reported.
Plain-English summary
Busse Hospital Disposables, Inc. is recalling its Single Shot Epidural Tray (Catalog Number 6183R1), distributed nationwide in quantities of approximately 425 units. The tray contains swab/swabstick drug products manufactured by Professional Disposables International (PDI).
The recall is due to uncertainty regarding the adequacy of the validation of test methods used to manufacture the swab/swabstick components. This means the manufacturing process was not sufficiently validated to ensure the devices meet required safety and quality standards.
The affected lot numbers are: 2030967, 2031172, 2031272, 2130029, 2130151, 2130298, 2130357, 2130459, 2130527, 2130593, 2130716, 2130863, 2130975, 2131088, 2131120, 2131224, and 2131248.
The recalled product
- Product
- Single Shot Epidural Tray Catalog Number: 6183R1
- Manufacturer
- Busse Hospital Disposables, Inc.
- Affected units
- 425
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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