Busse Hospital Disposables recalls SS 4.5MM Pellet Insertion Tray (Catalog B8128R1) due to uncertain drug test validation. Affected units have specific lot numbers and UDI codes. Consumers should contact 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 SS 4.5MM Pellet Insertion Trays with catalog number B8128R1 because drug safety tests may not be properly validated. This could affect medical use if the product doesn't meet safety standards.
The recall is due to uncertainty about whether the drug test methods used to make the product are validated properly. This could mean the product doesn't meet safety standards for medical use.
Healthcare professionals using the tray for medical procedures may be affected. Patients receiving treatments with this product could face risks if the drug validation is inadequate.
Check for catalog number B8128R1 on the tray. Affected units have lot numbers 2130197 and UDI code 00849233001855.
Reach out to Busse Hospital Disposables for specific recall details and instructions.
The recall is due to uncertainty about the adequacy of drug test validation methods used in manufacturing.
Lot number 2130197 is affected.
Look for catalog number B8128R1 and lot number 2130197 or UDI code 00849233001855.
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-1200-2022 — Busse Hospital Disposables Busse Hospital Disposables Hello, I own a Busse Hospital Disposables that is covered by recall Z-1200-2022 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.