Busse Hospital Disposables recalls Stereo Breast Biopsy Tray (Catalog 238: 2130565) due to uncertain drug test validation. Consumers should contact for details.
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
Busse Hospital Disposables is recalling Stereo Breast Biopsy Trays with catalog number 2383R1 and lot numbers 2130565. The recall is due to uncertainty about the drug test validation process used to make the products, which could affect safety.
The recall is based on uncertainty about the validation of drug test methods used to manufacture the products. This uncertainty could lead to potential safety issues with the drug products in the tray.
Healthcare professionals using the Stereo Breast Biopsy Tray for medical procedures are likely affected. Patients undergoing breast biopsies with this device may be at risk.
Check for catalog number 2383R1 and lot number 2130565 on the Stereo Breast Biopsy Tray. The unique device identifier (UDI) is 00849233004344.
Reach out to Busse Hospital Disposables for specific recall details and instructions.
The recall is due to uncertainty about the validation of drug test methods used to manufacture the products.
Contact Busse Hospital Disposables for specific recall details and instructions.
The recall is based on uncertainty about drug test validation, but no specific injury risk is stated.
We’ve drafted a message you can send Busse Hospital Disposables to request your refund or repair — edit it as you like.
Subject: Recall Z-1165-2022 — Busse Hospital Disposables Busse Hospital Disposables Hello, I own a Busse Hospital Disposables that is covered by recall Z-1165-2022 from Busse Hospital Disposables. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
