Busse Hospital Disposables, Inc. recalls Stereo Breast Biopsy Tray Catalog Number: 2383R1

Recall date

February 22, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1165-2022

FDA classification

Class II

Brand / firm

Busse Hospital Disposables, Inc.

Sold / distributed

Nationwide

Why it was recalled

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Stereo Breast Biopsy Tray Catalog Number: 2383R1