The Recall Desk
ModerateFDA (Devices)·Z-0543-2018·Announced 2018-02-14

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.

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 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
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 →

Same manufacturer · Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables

See all →