Busse Nerve Block Tray Swabs Recalled for Test Method Validation Uncertainty
Busse Hospital Disposables is recalling Nerve Block Tray kits containing swab drug products due to uncertainty regarding adequate validation of test methods during manufacturing. The recall involves 250 units distributed nationwide.
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: These are medical products used in clinical procedures (nerve blocks) where test method validation adequacy is uncertain. Although no illnesses or injuries have been reported, the validation inadequacy represents a potential quality and safety concern for products used directly in medical procedures, meeting the rubric criterion of risk-of-harm products where injury has not yet been reported.
Plain-English summary
Busse Hospital Disposables, Inc. is recalling Nerve Block Tray kits (Catalog Number 3764R2) containing swab/swabstick drug products manufactured by Professional Disposables International (PDI). The recall affects 250 units with a nationwide distribution pattern.
The recall was initiated because there is uncertainty regarding the adequacy of the validation of the test methods used during the manufacturing of the drug products. This means the validation procedures used to verify proper manufacturing and safety may be inadequate.
Affected product lot numbers are 2030839, 2030974, 2130490, 2130900, and 2131293. The Universal Device Identifier (UDI) is 00849233015197. The FDA has classified this as a Class II recall. No illnesses or injuries have been reported in association with this product.
The recalled product
- Product
- Nerve Block Tray Catalog Number: 3764R2
- Manufacturer
- Busse Hospital Disposables, Inc.
- Category
- Drug — Pharmaceutical
- Hazard
- validation-failure
- 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: 2030839 2030974 2130490 2130900 2131293 UDI: 00849233015197
Distribution
Distributed nationwide across the United States.
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