Busse Hospital Disposables recalls Core Biopsy Tray (Catalog 8673R4) due to uncertain drug test validation. Affected lots include 2031043, 2130119, 2130382, 2130830, 2130997. No remedy specified in recall notice.
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 Core Biopsy Trays with catalog number 8673R4 because drug products inside them may not be manufactured safely due to uncertain test validation. This affects medical use and requires attention from healthcare providers handling these trays.
The recall is due to uncertainty about whether the drug test methods used to manufacture the swab products are validated properly. This could mean the drug products might not be safe for medical use, though the exact risk isn't specified.
Healthcare providers using the Core Biopsy Trays for medical procedures are most at risk. The recall affects specific lot numbers produced by Busse Hospital Disposables.
Check for the catalog number 8673R4 on the Core Biopsy Tray. Affected lots include 2031043, 2130119, 2130382, 2130830, and 2130997. The product was sold by Busse Hospital Disposables.
Look for the catalog number 8673R4 and affected lot numbers on the Core Biopsy Tray.
The recall states there is uncertainty about the drug test validation, so the product may not be safe. No specific remedy is provided in the notice.
The recall notice does not specify any action steps, so contact Busse Hospital Disposables for further guidance.
Affected lots are 2031043, 2130119, 2130382, 2130830, and 2130997.
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-1176-2022 — Busse Hospital Disposables Busse Hospital Disposables Hello, I own a Busse Hospital Disposables that is covered by recall Z-1176-2022 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.
