Busse Hospital Disposables recalls IV Start Kit (Catalog 822) due to drug safety concerns from manufacturing validation uncertainty. Affected items have specific lot numbers and UDI codes.
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 their IV Start Kit (Tegaderm Dressing, Catheter Securement, Prevantics) with catalog number 822 because of uncertainty in the drug manufacturing validation process. This could affect patient safety if the product doesn't meet quality standards.
The recall is due to uncertainty in the manufacturing validation process for the drug products. This means the product might not meet quality standards, potentially affecting patient safety during medical procedures.
Healthcare professionals using the IV Start Kit for medical procedures are most at risk. Patients receiving treatments with this kit could be affected if the product is used.
Check for catalog number 822 on the kit. Lot numbers 2020514, 2020525, 2020734, 2120255, 2120304, 2120325, 2120439, and UDI code 00849233010017 are affected.
Look for catalog number 822, specific lot numbers, and UDI code 00849233010017 on the kit.
The recall is due to uncertainty in the manufacturing validation process for the drug products, which could affect quality standards.
The official notice does not specify a remedy, so check the product details to see if it matches the affected items.
Check for catalog number 822, lot numbers 2020514, 2020525, 2020734, 2120255, 2120304, 2120325, 2120439, and UDI code 00849233010017.
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-1147-2022 — Busse Hospital Disposables Busse Hospital Disposables Hello, I own a Busse Hospital Disposables that is covered by recall Z-1147-2022 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.
