Busse Hospital Epidural Trays Recalled for Manufacturing Validation Uncertainty
Busse Hospital Disposables is recalling Single Shot Epidural Trays due to uncertainty about whether manufacturing test methods were adequately validated. No illnesses or injuries have been reported.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard is theoretical—uncertainty about manufacturing test method validation—without documented product failure or patient harm. This is a precautionary manufacturing quality recall.
Plain-English summary
Busse Hospital Disposables, Inc. is recalling Single Shot Epidural Trays Catalog 1165 nationwide due to uncertainty regarding the adequacy of validation test methods used during manufacturing. The trays contain swab and swabstick components manufactured by Professional Disposables International (PDI).
The recall affects trays with lot numbers 2130290 and 2131184 (UDI: 00849233006485). The issue involves uncertainty about whether the test methods used to validate the manufacturing process were sufficient and adequate.
No illnesses or injuries have been reported. Healthcare facilities and medical professionals should discontinue use of affected trays and contact Busse Hospital Disposables, Inc. for replacement products or further instructions. Patients with questions should consult their healthcare provider.
The recalled product
- Product
- Single Shot Epidural Tray Catalog 1165
- 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: 2130290 2131184 UDI: 00849233006485
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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