Busse Bone Marrow Biopsy Tray Recalled for Foreign Matter
Busse Hospital Disposables is recalling Safety Deluxe Bone Marrow Biopsy/Aspiration 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 source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables is recalling 15 cases of Safety Deluxe Bone Marrow Biopsy/Aspiration Trays, Catalog # 986. The product is used for surgical procedures and was distributed nationwide in the United States.
The recall was initiated because the trays may contain loose polypropylene foreign matter above release specification. The affected lots are 1620888 (expiration date 12/30/2017) and 1620367 (expiration date 09/01/2017).
Healthcare facilities and consumers should stop using these products and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Safety Deluxe Bone Marrow Biopsy/Aspiration Tray, Catalog # 986 Product Usage: Surgical procedure
- Category
- Medical Device — Surgical Trays
- Hazard
- Affected units
- 15
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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