Busse Hospital Disposables recalls 4.5MM Pellet Insert: Catalog B1360, Lot 2010336. Uncertainty in drug test validation may affect product safety. Consumers should check their items.
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 4.5MM Pellet Insertion Trays with Catalog Number B1360. The recall is due to concerns about the drug test validation process used to make the products, which could affect safety.
The recall is triggered by uncertainty in the validation of test methods used to manufacture the drug products. This uncertainty could potentially affect the safety and effectiveness of the products.
Healthcare professionals and patients using the 4.5MM Pellet Insertion Tray with Catalog Number B1360 are likely affected. Those using the product for medical procedures may be at higher risk.
Check for Catalog Number B1360 and Lot Number 2010336 on the 4.5MM Pellet Insertion Tray with Large Gloves. The product was sold with the UDI 00849233004627.
Look for Catalog Number B1360 and Lot Number 2010336 on the 4.5MM Pellet Insertion Tray with Large Gloves.
The recall is due to uncertainty in the validation of test methods used to manufacture the drug products, so safety is not confirmed.
The recall record does not specify a remedy, so check with Busse Hospital Disposables for further instructions.
Check for Catalog Number B1360 and Lot Number 2010336 on the product, or the UDI 00849233004627.
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-1185-2022 — Busse Hospital Disposables Busse Hospital Disposables Hello, I own a Busse Hospital Disposables that is covered by recall Z-1185-2022 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.
