Busse Bone Marrow Biopsy Tray Recalled for Foreign Matter
Robert Busse & Co. is recalling 5 cases of Safety Deluxe Bone Marrow Biopsy/Aspiration Trays due to the presence of 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 voluntary precautionary recall.
Plain-English summary
Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables is recalling 5 cases of Safety Deluxe Bone Marrow Biopsy/Aspiration Trays with Biopsy Needle and Aspiration Needle Sterile, Catalog # 985. The product is used for surgical procedures and was distributed nationwide in the United States.
The recall is being conducted because the BD SafetyGlide Needle 22GA 1-1/2 inch included in the tray may contain loose polypropylene foreign matter that exceeds release specifications. The affected lot number is 1720047, with an expiration date of 02/20/2018.
Healthcare facilities and consumers should stop using the affected product and contact the recalling firm for further instructions or a refund.
The recalled product
- Product
- Safety Deluxe Bone Marrow Biopsy/ Aspiration Tray with Biopsy Needle and Aspiration Needle Sterile, Catalog # 985 Product Usage: Surgical procedure
- Hazard
- Affected units
- 5
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/Expiration Dates: 1) 1720047/Expiration Date: 02/20/2018
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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