Single Shot Epidural Tray Recalled Due to Test Validation Uncertainty
Single Shot Epidural Trays made by Busse Hospital Disposables are being recalled nationwide due to inadequate validation of the test methods used to manufacture the product. The recall affects 400 units.
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: This is an FDA Class II precautionary recall issued due to uncertainty regarding adequate validation of manufacturing test methods. Without reported evidence of actual harm, and with the hazard being a validation concern rather than a confirmed product defect, this ranks as moderate severity.
Plain-English summary
Single Shot Epidural Trays, Catalog Number 8417, manufactured by Busse Hospital Disposables, Inc., are being recalled nationwide. The recall involves 400 units, identified by lot numbers 2130077, 2130313, 2130630, 2130945, and 2131091.
The FDA issued this Class II recall due to uncertainty regarding the adequacy of validation of the test methods used to manufacture these trays. The specific concern is whether the methods used to test and validate the product's safety and quality were themselves properly validated during the manufacturing process.
Healthcare facilities and medical practitioners who have received these epidural trays should contact Busse Hospital Disposables, Inc., or the FDA for instructions regarding the recalled units. The recall is nationwide and affects all 400 units distributed.
The recalled product
- Product
- Single Shot Epidural Tray Catalog Number: 8417
- Manufacturer
- Busse Hospital Disposables, Inc.
- Affected units
- 400
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: 2130077 2130313 2130630 2130945 2131091 UDI: 00849233016804
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.
See all 58 products in this recall →Related recalls
Same manufacturer · Busse Hospital Disposables, Inc.
See all →- SevereDressing change tray recalled for sterility assurance failure
FDA (Devices) · 2024-01-10
- SevereTracheostomy care kits recalled for sterility assurance failure
FDA (Devices) · 2024-01-10
- SevereTracheostomy care sets recalled for sterility assurance failure
FDA (Devices) · 2024-01-10
- ModerateSurgical Injection Tray Recalled Due to Adhesive Liner Defect
FDA (Devices) · 2022-12-07
- Moderate3M Steri-Drape Surgical Drapes Recalled Due to Adhesive Liner Defect
FDA (Devices) · 2022-12-07
Same hazard · manufacturing validation uncertainty
See all →- ModeratePump Refill Kit Recalled Over Uncertain Manufacturing Test Method Validation
FDA (Devices) · 2022-06-08
- ModerateBusse Hospital Disposables Convenience Kit Swab Recall for Test Validation Uncertainty
FDA (Devices) · 2022-06-08
- ModerateProcedural Accessory Kit Recalled for Manufacturing Validation Uncertainty
FDA (Devices) · 2022-06-08
- ModerateMedical Device Swabs Recalled Due to Manufacturing Validation Uncertainty
FDA (Devices) · 2022-05-25