Busse Hospital Disposables recalls 4.5 MM Pellet Insertion Trays with catalog number B812:1R1 due to uncertainty in drug manufacturing validation. Affected units include specific lot numbers and UDI codes.
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 4.5 MM Pellet Insertion Trays with catalog number B8121R1 because drug products in these kits may have manufacturing validation issues. This recall is due to uncertainty about the test methods used to ensure drug safety.
The recall is triggered by uncertainty in the validation of test methods used to manufacture the drug products. This could mean the drug products might not meet safety standards, though the exact risk is unclear.
Healthcare professionals using these trays for drug administration are most at risk. Patients receiving drugs from these kits may be affected if the product is used.
Check for catalog number B8121R1 on the tray. Lot numbers 2031076 and 2130823, and UDI code 00849233017306 are also associated with this recall.
Identify the catalog number, lot numbers, and UDI code to confirm if your tray is affected.
The recall is due to uncertainty in the validation of test methods used to manufacture the drug products.
The official notice does not specify a remedy, so check the product details to see if it is affected.
Look for catalog number B8121R1, lot numbers 2031076 or 2130823, and UDI code 00849233017306.
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-1199-2022 — Busse Hospital Disposables Busse Hospital Disposables Hello, I own a Busse Hospital Disposables that is covered by recall Z-1199-2022 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.
