Busse Hospital Disposables recalls Female SS 3.5MM Pellet Insertion Tray (Catalog B1568) due to uncertain drug test validation. Affected units have specific lot numbers; stop using immediately.
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 B1568 because drug safety tests may not be properly validated. This could affect users who have the specific lot numbers listed in the recall.
The recall is due to uncertainty about whether the drug test methods used to manufacture the products were validated correctly. This could mean the drug products might not be safe for use in medical procedures.
Users of the Female SS 3.5MM Pellet Insertion Tray with catalog number B1568 and specific lot numbers are affected. Healthcare professionals using these trays for medical procedures are most at risk.
Check for the catalog number B1568 on the tray. Affected units have lot numbers 2130338 or 2130562. The unique device identifier (UDI) is 00849233005525.
Discontinue use of the Female SS 3.5MM Pellet Insertion Tray if it has the catalog number B1568 and lot numbers 2130338 or 2130562.
The recall is due to uncertainty about the adequacy of test methods used to validate the drug products, which could affect safety.
Lot numbers 2130338 and 2130562 are affected.
Check for catalog number B1568 and lot numbers 2130338 or 2130562 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-1194-2022 — Busse Hospital Disposables Busse Hospital Disposables Hello, I own a Busse Hospital Disposables that is covered by recall Z-1194-2022 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.
