Nerve Block Tray Recalled Due to Manufacturing Validation Uncertainty
Busse Hospital Disposables is recalling Nerve Block Trays containing swab and swabstick products due to uncertainty about manufacturing test method validation. Affected lot numbers should be discontinued.
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 medical device with manufacturing process validation issues affecting product quality. No illnesses or injuries reported, making this a preventive recall addressing potential risks from inadequate test method validation.
Plain-English summary
Busse Hospital Disposables, Inc. is recalling Nerve Block Trays (Catalog Number 9342) containing swab and swabstick drug products manufactured by Professional Disposables International. The recall affects 64 units distributed nationwide.
The recall was initiated due to uncertainty regarding the adequacy of the validation of test methods used during manufacturing. This raises concerns about whether the products meet required manufacturing standards and quality expectations.
Customers who have received affected products with Lot Numbers 2031019S or 2130222S (UDI: 00849233009073) should discontinue use. Contact Busse Hospital Disposables, Inc. for instructions on product return or replacement.
The recalled product
- Product
- Nerve Block Tray Catalog Number: 9342
- Manufacturer
- Busse Hospital Disposables, Inc.
- Category
- Medical Device — Surgical Trays
- Hazard
- quality-control
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: 2031019S 2130222S UDI: 00849233009073
Distribution
Distributed nationwide across the United States.
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