Busse Hospital Disposables recalls SS 3.5Mm Pel: Tray with Catalog B1352 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 Catalog Number B1352 because the drug products they contain may have manufacturing validation issues. This recall affects healthcare professionals using these trays for 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 drug products might not be safe or effective for medical use.
Healthcare professionals using the recalled trays for medical procedures are most at risk. The recall applies to specific lot numbers and catalog numbers sold through Busse Hospital Disposables.
Check for Catalog Number B1352 on the tray. Lot Numbers 2010298 and UDI 00849233004719 are associated with this recall.
Verify the catalog number and lot numbers on the tray to confirm if it is recalled.
The recall is due to uncertainty about the adequacy of test methods used to manufacture the drug products.
The official notice does not specify a remedy, so check the product details to confirm if it is recalled.
Look for Catalog Number B1352, Lot Number 2010298, or UDI 00849233004719 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-1181-2022 — Busse Hospital Disposables Busse Hospital Disposables Hello, I own a Busse Hospital Disposables that is covered by recall Z-1181-2022 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.
