Busse Hospital Disposables recalls CVC Dressing Change Kit (Catalog 2491R1) due to uncertain drug validation. Affected lots include 2020472, 2020519, 2020651, 2020759. No specific action steps listed in recall notice.
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 CVC Dressing Change Kit Catalog Number 2491R1 because drug products in the kit may not have been properly validated. This recall is due to uncertainty about the manufacturing test methods, which could affect safety.
The recall involves drug products in the kit that were manufactured by Professional Disposables International (PDI). The issue is uncertainty about whether the test methods used to validate the drug products were adequate, which could impact safety.
Healthcare professionals using the CVC Dressing Change Kit for central venous catheter care are likely affected. Patients receiving treatments through these kits may be at risk if the kit is used without proper validation.
Check for Catalog Number 2491R1 on the kit. Affected lots include 2020472, 2020519, 2020651, and 2020759. The kit may also have a UDI code 00849233004481.
Look for Catalog Number 2491R1 and affected lot numbers (2020472, 2020519, 2020651, 2020759) on the kit.
The recall is due to uncertainty about the adequacy of test methods used to manufacture the drug products in the kit, which could affect safety.
The recall notice does not specify any action steps for affected kits.
Affected lots include 2020472, 2020519, 2020651, and 2020759.
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-1166-2022 — Busse Hospital Disposables Busse Hospital Disposables Hello, I own a Busse Hospital Disposables that is covered by recall Z-1166-2022 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.
