FDA Recalls Pellet Insertion Trays Due to Validation Method Uncertainty
Busse Hospital Disposables is recalling 3.2MM Pellet Insertion Trays due to inadequate validation of manufacturing test methods. The recall affects 150 units distributed nationwide.
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 a FDA Class II medical device recall without reported hospitalizations or injuries. The hazard is inadequate validation of manufacturing test methods—a quality-control issue representing theoretical risk of harm if the device does not meet intended specifications. Per the rubric, risk-of-harm products where injury has not been reported score as High (3).
Plain-English summary
Busse Hospital Disposables, Inc. is recalling the 3.2MM Pellet Insertion Tray (Catalog Number B9743). A total of 150 units with lot numbers 2031128, 2130202, and 2131304 have been recalled. The recalled product was distributed nationwide.
The recall was initiated due to uncertainty regarding the adequacy of validation of the test methods used to manufacture the device. The manufacturer has identified that the validation of manufacturing test methods may not adequately confirm device specifications and safety standards.
The FDA classified this recall as Class II, indicating a potential health hazard. Healthcare facilities with affected lots should identify impacted devices for appropriate management.
The recalled product
- Product
- 3.2MM Pellet Insertion Tray Catalog Number: B9743
- Manufacturer
- Busse Hospital Disposables, Inc.
- Hazard
- Affected units
- 150
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: 2031128 2130202 2131304 UDI: 00849233011649
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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