Busse Hospital Disposables recalls SS 3.2MM Pellet Insertion Tray (Catalog B8110R1) due to uncertainty in drug manufacturing validation. Affected units have specific lot numbers. No remedy provided in official 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 their SS 3.2MM Pellet Insertion Tray (Catalog B8110R1) because drug products in these kits may have manufacturing validation issues. This could affect patient safety if used improperly.
The recall is due to uncertainty about whether the test methods used to manufacture the drug products are adequate. This could mean the drug products might not be safe for use in patients.
Healthcare professionals using these trays for drug administration may be affected. Patients receiving drugs from these kits could be at risk if the validation issues impact drug safety.
Check for Catalog Number B8110R1 on the tray. Affected units include specific lot numbers: 2030982, 2031072, 2130198, 2130352, 2130706, 2130876.
Look for Catalog Number B8110R1 and the listed lot numbers on the tray.
The recall is due to uncertainty about the adequacy of test methods used to manufacture the drug products in these kits.
The official notice does not provide a remedy, so no specific action is required beyond checking if you have the affected lot numbers.
The recall indicates potential manufacturing validation issues, but the official notice does not specify if this poses a direct safety risk to users.
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-1198-2022 — Busse Hospital Disposables Busse Hospital Disposables Hello, I own a Busse Hospital Disposables that is covered by recall Z-1198-2022 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.
