Busse Hospital Disposables recalls Male SS 4.5MM Pellet Insertion Tray (Catalog B9176R1) due to uncertainty in drug test validation. 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 Male SS 4.5MM Pellet Insertion Trays with catalog number B9176R1 because drug test validation methods may be inadequate. This could affect the safety of the drug products in these kits.
The recall is due to uncertainty about whether the test methods used to validate the drug products are adequate. This could mean the drug products might not be safe for use, but the exact risk is not clearly defined.
Users of the Male SS 4.5MM Pellet Insertion Tray with catalog number B9176R1 and specific lot numbers are affected. Healthcare professionals using these trays for drug administration are most at risk.
Check for catalog number B9176R1 on the tray. Affected units have lot numbers 2031047, 2031162, 2130578, or 2130723. The UDI code 00849233011151 is also associated with these units.
Look for catalog number B9176R1 and lot numbers 2031047, 2031162, 2130578, or 2130723 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.
The official recall notice does not specify a remedy, so contact Busse Hospital Disposables directly for guidance.
Lot numbers 2031047, 2031162, 2130578, and 2130723 are affected.
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-1202-2022 — Busse Hospital Disposables Busse Hospital Disposables Hello, I own a Busse Hospital Disposables that is covered by recall Z-1202-2022 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.
