Single Shot Epidural Tray recalled due to inadequate test method validation
Busse Hospital Disposables is recalling Single Shot Epidural Trays because swab components from Professional Disposables International were manufactured with unvalidated test methods.
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: Class II medical device recall involving swabs used in invasive epidural procedures where manufacturing test method validation is uncertain. No illnesses or injuries have been reported, but the potential for contamination in high-risk injection supplies creates a high-risk situation.
Plain-English summary
Busse Hospital Disposables, Inc. is recalling Single Shot Epidural Trays, Catalog Number 6797R2. The kits contain swab/swabstick components manufactured by Professional Disposables International (PDI). Approximately 40 units with lot numbers 2030835, 2031025, 2031217, and 2130006 were distributed nationwide. The UDI for these products is 00849233014657.
The recall was initiated because PDI was unable to demonstrate adequate validation of the manufacturing test methods used to produce the swab components. This validation uncertainty creates a potential risk of product contamination.
Healthcare facilities and medical professionals who received affected epidural trays should discontinue use and contact their supplier for replacement products. For additional information, contact Busse Hospital Disposables, Inc. or the FDA.
The recalled product
- Product
- Single Shot Epidural Tray Catalog Number: 6797R2
- Manufacturer
- Busse Hospital Disposables, Inc.
- Affected units
- 40
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: 2030835 2031025 2031217 2130006 UDI: 00849233014657
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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