Busse Hospital Disposables recalls Bone Marrow Biopsy Trays (Catalog 8917R1) with specific lot numbers due to potential drug safety issues from manufacturing validation uncertainty.
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 Bone Marrow Biopsy Trays with catalog number 8917R1 and specific lot numbers because the drug products inside may not have been properly validated during manufacturing. This recall affects medical professionals using these trays for bone marrow biopsies.
The recall is due to uncertainty about whether the drug products inside the trays were properly validated during manufacturing. This means there could be issues with the safety and effectiveness of the drugs used in bone marrow biopsies.
Medical professionals who use Bone Marrow Biopsy Trays with catalog number 8917R1 and the listed lot numbers are most at risk. The recall targets hospitals and clinics that use these specific trays for medical procedures.
Check for Bone Marrow Biopsy Trays with catalog number 8917R1 and lot numbers 2020741, 2120119, 2120342, or 2120630. The product also has a unique device identifier (UDI) of 00849233002012.
Identify the catalog number and lot numbers to confirm if your Bone Marrow Biopsy Tray is affected.
The recall is due to uncertainty about the adequacy of the validation of the test methods used to manufacture the drug products inside the trays.
Lot numbers 2020741, 2120119, 2120342, and 2120630 are affected.
Check for catalog number 8917R1 and the listed lot numbers on the product label.
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-1177-2022 — Busse Hospital Disposables Busse Hospital Disposables Hello, I own a Busse Hospital Disposables that is covered by recall Z-1177-2022 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.
