Busse Hospital Disposables recalls 3.2MM Pellet Insertion Trays with catalog number B734:2031074-2130783 due to drug safety concerns from manufacturing validation issues.
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 3.2 million pellet insertion trays with specific catalog numbers and lot numbers because of uncertainty in the drug manufacturing validation process. This recall is important because it addresses potential safety risks related to the drug products contained in these trays.
The recall is due to uncertainty about the adequacy of the test methods used to validate the drug products during manufacturing. This uncertainty could potentially affect the safety and effectiveness of the drug products contained in the trays.
Healthcare professionals and facilities using Busse Hospital Disposables' pellet insertion trays with catalog number B7345R1 and the listed lot numbers are most at risk. Patients receiving these drug products may also be affected.
Check for the catalog number B7345R1 and lot numbers 2031074, 2031227, 2130194, 2130535, or 2130783 on the tray. The product was sold with a unique device identifier (UDI) 00849233016996.
Verify the catalog number and lot numbers on the tray to confirm if it is part of the recall.
The recall is due to uncertainty about the adequacy of the test methods used to validate the drug products during manufacturing.
The official notice does not specify a remedy, so check the product details to confirm if it is part of the recall.
Look for catalog number B7345R1 and lot numbers 2031074, 2031227, 2130194, 2130535, or 2130783 on the tray.
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-1197-2022 — Busse Hospital Disposables Busse Hospital Disposables Hello, I own a Busse Hospital Disposables that is covered by recall Z-1197-2022 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.
