The Recall Desk
ModerateFDA (Devices)·Z-0546-2018·Announced 2018-02-14

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.

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 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
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 →

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

See all →