Sterile Epidural Tray Recalled Due to Validation Uncertainty
Busse Hospital Disposables is recalling Sterile Epidural Trays nationwide due to uncertainty about whether test method validation was adequate. No illnesses or injuries have been reported.
What this means for you
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: FDA Class II recall involving medical devices used in invasive procedures with no reported illnesses or injuries. The hazard is uncertainty in validation of sterilization test methods, constituting a risk-of-harm product without yet-reported injury, meeting the criteria for High severity.
Plain-English summary
Busse Hospital Disposables, Inc. is recalling the Sterile Epidural Tray (Catalog Number 6259R2) nationwide due to uncertainty regarding the adequacy of validation of the test methods used to manufacture swab/swabstick drug products contained in the kits. The swabs are manufactured by Professional Disposables International (PDI).
The affected lot numbers are 2130839, 2131167, 2131230, and 2131210. A total of 50 units were distributed nationwide.
No illnesses or injuries related to this product have been reported. Consumers and healthcare facilities in possession of affected lots should discontinue use and contact Busse Hospital Disposables for instructions on product return or replacement.
The recalled product
- Product
- Sterile Epidural Tray Catalog Number: 6259R2
- Manufacturer
- Busse Hospital Disposables, Inc.
- Hazard
- validation-failure
- sterilization-failure
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: 2130839 2131167 2131230 2131210 UDI: 00849233000278
Distribution
Distributed nationwide across the United States.
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