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.
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 2/5 (Moderate).
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.
See all 7 products in this recall →Related recalls
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