Busse Hospital Disposables recalls Male SS 4.5MM Pellet Insertion Tray (Catalog B1570) due to uncertain drug test validation. Affected units have 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 their Male SS 4.5MM Pellet Insertion Tray (Catalog B1570) because drug safety testing during manufacturing may not be reliable. This could affect medical use and requires verification of the product's safety.
The recall is due to uncertainty about whether the drug test methods used to manufacture the products were validated properly. This could mean the drug products might not be safe for use in medical procedures.
Healthcare professionals using this tray for medical procedures may be affected. Patients receiving treatments with this product could be at risk if the drug safety is compromised.
Check for Catalog Number B1570 on the tray. Lot Numbers 2130324 and UDI code 00849233005556 are associated with this recall.
Verify the Catalog Number B1570, Lot Number 2130324, and UDI code 00849233005556 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.
Check for the Catalog Number B1570, Lot Number 2130324, and UDI code 00849233005556 to confirm if it's affected.
The official recall does not provide a remedy or fix for this product.
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-1195-2022 — Busse Hospital Disposables Busse Hospital Disposables Hello, I own a Busse Hospital Disposables that is covered by recall Z-1195-2022 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.
