Busse Hospital Disposables recalls SS 4.5MM Pellet Insertion Tray with Medium Gloves (Catalog B1365R1) due to uncertainty in drug manufacturing validation. Affected units include specific lot numbers and UDI.
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 4.5MM Pellet Insertion Trays with Medium Gloves (Catalog B1365R1) because the drug products in these kits may not have been properly validated during manufacturing. This could affect the safety and effectiveness of the products.
The recall is due to uncertainty about whether the test methods used to validate the drug products were adequate during manufacturing. This could mean the products might not work as intended or could be unsafe.
Healthcare professionals using these disposables in medical settings are most at risk. Patients receiving treatments with these products may also be affected.
Check for the catalog number B1365R1 on the tray. Lot numbers 2110128 and 2110279, and UDI 00849233004412 are also associated with this recall.
Look for the catalog number B1365R1, lot numbers 2110128 or 2110279, and UDI 00849233004412 on the tray.
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 or action steps for affected products.
Check for the catalog number B1365R1, lot numbers 2110128 or 2110279, and UDI 00849233004412 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-1189-2022 — Busse Hospital Disposables Busse Hospital Disposables Hello, I own a Busse Hospital Disposables that is covered by recall Z-1189-2022 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.
