Busse Hospital Disposables recalls SS 3.5MM Pellet Insertion Tray with Medium Gloves (Catalog B1354R1) due to drug safety concerns 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 SS 3.5MM Pellet Insertion Trays with Medium Gloves (Catalog B135:4R1) because the drug products they contain may have manufacturing validation issues. This could affect patient safety if used in medical procedures.
The recall is due to uncertainty about whether the test methods used to manufacture the drug products are adequate. This could mean the drugs might not be safe for medical use, potentially causing harm to patients.
Healthcare professionals using these trays for medical procedures are most at risk. Patients receiving treatments with these products could be affected if the drug products are unsafe.
Check for the catalog number B1354R1 on the tray. Lot numbers 2110102, 2110090, and 2110268 are also associated with this recall.
Look for the catalog number B1354R1 and lot numbers 2110102, 2110090, or 2110268 on the tray.
The recall is due to uncertainty about the adequacy of test methods used to manufacture the drug products, which could affect safety.
The official notice does not specify a remedy, so check with Busse Hospital Disposables for further instructions.
The recall is for potential safety concerns, but the official notice does not describe specific injury risks.
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-1184-2022 — Busse Hospital Disposables Busse Hospital Disposables Hello, I own a Busse Hospital Disposables that is covered by recall Z-1184-2022 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.
