Busse Hospital Disposables recalls Procedure Tray Catalog 1065 due to uncertain drug validation. Affected lots include 2030699 and 2130342. Contact for remedy 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 Procedure Tray Catalog 1065 because drug products inside may not be safely manufactured. This could affect medical use safety.
The drug products in these kits were manufactured using test methods that may not have been properly validated. This uncertainty could lead to unsafe drug products if used in medical procedures.
Healthcare providers using the Procedure Tray Catalog 1065 for medical procedures may be affected. Patients receiving treatments through these kits could be at risk if the drug products are unsafe.
Check for Procedure Tray Catalog 106: Lot numbers 2030699 or 2130352. The UDI code 00849233003354 identifies the affected items.
Identify the lot number and UDI code on the Procedure Tray Catalog 1065 to confirm if it's affected.
Procedure Tray Catalog 1065 with lot numbers 2030699 and 2130342.
Check for lot numbers 2030699 or 2130342 on the Procedure Tray Catalog 1065, or UDI code 00849233003354.
The recall record does not specify a remedy, so contact Busse Hospital Disposables for further instructions.
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-1148-2022 — Busse Hospital Disposables Busse Hospital Disposables Hello, I own a Busse Hospital Disposables that is covered by recall Z-1148-2022 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.
