Busse Hospital Disposables recalls Female SS 3.5MM Pellet Insertion Tray (Catalog B9175R1) due to uncertain drug validation methods. Affected units include specific lot numbers. Consumers should contact Busse for details.
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 Female SS 3.5MM Pellet Insertion Trays with catalog number B9175R1 because the drug products inside may not be manufactured with validated test methods. This could affect safety if used incorrectly.
The recall is due to uncertainty about whether the drug products inside the trays were manufactured using validated test methods. This could mean the drug products might not be safe or effective for medical use.
Users of the Female SS 3.5MM Pellet Insertion Tray with catalog number B9175R1 are affected. Healthcare professionals using these trays for medical procedures are most at risk.
Check for catalog number B9175R1 on the tray. Lot numbers 2030875, 2030980, 2031048, 2031096, and 2130563, 2130722 are affected. The unique device identifier (UDI) 00849233011182 is also associated with this recall.
Reach out to Busse Hospital Disposables directly for specific instructions on handling the recalled product.
The recall is due to uncertainty about the adequacy of test methods used to manufacture the drug products inside the trays.
Lot numbers 2030875, 2030980, 2031048, 2031096, and 2130563, 2130722 are affected.
Check for catalog number B9175R1 and the specific lot numbers listed in the recall notice.
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-1201-2022 — Busse Hospital Disposables Busse Hospital Disposables Hello, I own a Busse Hospital Disposables that is covered by recall Z-1201-2022 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
