FDAClass IIJune 8, 2022

Stereo Breast Biopsy Tray recall

Stereo Breast Biopsy Tray Catalog Number: 2383R1

Why was Stereo Breast Biopsy Tray 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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Numbers: 2130565 UDI: 00849233004344

Product
Stereo Breast Biopsy Tray Catalog Number: 2383R1
Recalling firm
Busse Hospital Disposables, Inc.
Quantity
23 units
Distribution
Nationwide
Recall date
June 8, 2022
Classification
Class II
Status
Terminated
Agency
FDA (device)
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