Medical Device Pellet Insertion Tray Recalled for Manufacturing Test Method Validation Issues
Busse Hospital Disposables is recalling its SS 4.5MM Pellet Insertion Tray nationwide due to uncertainty regarding the adequacy of the validation of the manufacturing test methods used.
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: This is an FDA Class II medical device where manufacturing test method validation is uncertain. Although no illnesses or injuries have been reported, the inadequate validation of testing procedures for a surgical device represents a risk-of-harm scenario, warranting a High severity rating.
Plain-English summary
Busse Hospital Disposables, Inc. is recalling the SS 4.5MM Pellet Insertion Tray (Catalog Number B9807). This product was distributed nationwide. The affected product has Lot Number 2031228 and UDI 00849233003552.
The recall is due to uncertainty regarding the adequacy of the validation of the test methods used to manufacture the product. This means the manufacturer's testing procedures may not have been adequately validated to ensure the product meets all required safety and performance specifications.
This is classified as an FDA Class II medical device recall. Additional information is available from the U.S. Food and Drug Administration.
The recalled product
- Product
- SS 4.5MM Pellet Insertion Tray Catalog Number: B9807
- Manufacturer
- Busse Hospital Disposables, Inc.
- Category
- Medical Device
- Affected units
- 50
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: 2031228 UDI: 00849233003552
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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