Busse Hospital Disposables recalls Pellet Insertion Tray (Catalog B1654) due to potential drug safety issues from manufacturing test validation uncertainty.
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 Pellet Insert: Insertion Tray (Catalog B1654) because drug safety testing during manufacturing may not be reliable. This could affect medical use if the product doesn't work as intended.
The recall is due to uncertainty about whether the drug manufacturing test methods were validated correctly. This could mean the drug product might not work as intended during medical procedures.
Healthcare professionals using the Pellet Insertion Tray for medical procedures may be affected. Patients receiving treatments with this product could face risks if the drug isn't properly validated.
Check for Catalog Number B1654 on the Pellet Insertion Tray. Lot Numbers 2130616 and UDI 00849233006027 are associated with this recall.
Identify the Catalog Number B1654, Lot Number 2130616, or UDI 00849233006027 on the Pellet Insertion Tray.
The recall is due to uncertainty about the adequacy of test methods used to manufacture the drug products, which could affect their reliability.
The official recall notice does not specify a remedy or action steps for affected products.
Look for Catalog Number B1654, Lot Number 2130616, or UDI 00849233006027 on the Pellet Insertion 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-1196-2022 — Busse Hospital Disposables Busse Hospital Disposables Hello, I own a Busse Hospital Disposables that is covered by recall Z-1196-2022 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.
