Pellet Insertion Tray Recall for Uncertain Manufacturing Test Validation
Busse Hospital Disposables is recalling SS 3.5MM Pellet Insertion Tray kits nationwide. The kits contain swab products with uncertain manufacturing test method validation.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II medical device recall with no reported illnesses or injuries. The recall is precautionary in nature, addressing uncertainty about the validation of manufacturing test methods rather than a known defect or harm.
Plain-English summary
Busse Hospital Disposables, Inc. is recalling SS 3.5MM Pellet Insertion Trays with Medium Gloves nationwide. The affected lot numbers are 2110102, 2110090, and 2110268 (UDI: 00849233004641).
The recall is due to uncertainty regarding the adequacy of validation of the test methods used to manufacture swab and swabstick products included in these convenience kits. The swab products are manufactured by Professional Disposables International (PDI).
Healthcare facilities, distributors, and healthcare providers in possession of affected lots should verify their inventory against the lot numbers listed and contact Busse Hospital Disposables for instructions regarding this recall.
The recalled product
- Product
- SS 3.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1354R1
- Manufacturer
- Busse Hospital Disposables, Inc.
- Category
- Medical Device
- Hazard
- Affected units
- 90
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: 2110102 2110090 2110268 UDI: 00849233004641
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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