Single Shot Epidural Tray Kits Recalled Due to Manufacturing Validation Uncertainty
Busse Hospital Disposables recalls Single Shot Epidural Tray kits due to uncertainty about the adequacy of test method validation in manufacturing. No illnesses 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 no reported illnesses or injuries. The hazard is based on inadequate validation of manufacturing test methods rather than a confirmed product defect. Per FDA classification guidance, Class II recalls without reported harm are capped at High severity.
Plain-English summary
Busse Hospital Disposables, Inc. is recalling Single Shot Epidural Tray kits, Catalog Number 8139R2, with Lot Numbers 2031049 and 2131128, distributed nationwide. These kits contain swab and swabstick drug products manufactured by Professional Disposables International.
The recall was issued due to uncertainty regarding the adequacy of the validation of the test methods used to manufacture the swab and swabstick drug products contained in these kits. The manufacturer determined that the validation protocols may not have been sufficiently rigorous to ensure product quality.
Healthcare providers and facilities who have received these kits should discontinue use and contact Busse Hospital Disposables, Inc. for instructions on return or replacement.
No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- Single Shot Epidural Tray - 18G Catalog Number: 8139R2
- Manufacturer
- Busse Hospital Disposables, Inc.
- Hazard
- Affected units
- 20
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: 2031049 2131128 UDI: 00849233015890
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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