Busse Safety-Deluxe Biopsy Tray Recalled for Foreign Matter
Robert Busse & Co. is recalling Safety-Deluxe Basic Soft Tissue Biopsy Trays because they may contain loose polypropylene foreign matter.
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: The recall is classified as FDA Class II, and the hazard involves foreign matter contamination without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables is recalling 28 cases of Safety-Deluxe Basic Soft Tissue Biopsy Tray without Biopsy Needle, Catalog # 977. The recall was initiated because the product may contain loose polypropylene foreign matter above release specification.
The affected product is used for surgical procedures. The recall covers two specific lots: Lot 1610197 with an expiration date of 12/01/2018, and Lot 1610277 with an expiration date of 03/01/2019. The product was distributed nationwide in the United States.
Healthcare facilities and consumers should stop using the affected trays and contact the manufacturer for further instructions or a refund.
The recalled product
- Product
- Safety-Deluxe Basic Soft Tissue Biopsy Tray without Biopsy Needle, Catalog # 977 Product Usage: Surgical procedure
- Category
- Medical Device — Surgical Trays
- Hazard
- Affected units
- 28
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 (2)
- Lot Numbers/Expiration Dates: 1) 1610197/Expiration Date: 12/01/2018
- 2) 1610277/Expiration Date: 03/01/2019
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables 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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