Busse Hospital Disposables recalls Universal Tray Catalog 1567 with specific lot numbers due to uncertainty in drug manufacturing validation methods. Consumers should check their product details to determine if affected.
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 Universal Tray Catalog 1567 with specific lot numbers because the drug products inside may not have been properly validated during manufacturing. This could potentially lead to unsafe drug products.
The drug products in these trays were manufactured using test methods that may not have been adequately validated. This uncertainty could result in unsafe drug products that might not meet quality standards.
Patients using Busse Universal Tray Catalog 1567 with the listed lot numbers may be affected. Healthcare providers using these trays for drug administration are most at risk.
Check the Universal Tray Catalog 1567 with lot numbers 2130419, 2130880, or 2131187. The Unique Device Identifier (UDI) is 00849233005655.
Identify if your Universal Tray Catalog 1567 has the lot numbers 2130419, 2130880, or 2131187.
The drug products in these trays may not have been properly validated during manufacturing, which could lead to unsafe products.
Check the lot numbers on your Universal Tray Catalog 1567. If it matches the listed lot numbers, contact Busse Hospital Disposables for further instructions.
The recall is due to uncertainty in manufacturing validation, not a specific risk of injury. The official notice does not state that serious injury is likely.
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-1154-2022 — Busse Hospital Disposables Busse Hospital Disposables Hello, I own a Busse Hospital Disposables that is covered by recall Z-1154-2022 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.
