Busse Hospital Disposables recalls Single Shot Epidural Trays (Catalog 8417) with specific lot numbers due to potential drug safety issues from manufacturing validation uncertainty.
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 Single Shot Epidural Trays with catalog number 8417 and specific lot numbers because the drug products inside may not be manufactured safely due to uncertainty in testing methods. This could affect medical use and requires attention to prevent potential safety risks.
The recall is due to uncertainty about whether the manufacturing test methods for the drug products were validated properly. This could mean the drugs might not be safe for use in medical procedures, potentially leading to health risks.
Healthcare providers using these trays for epidural procedures are most at risk. Patients receiving epidural treatments with these trays may be affected if the drug products are unsafe.
Check for the catalog number 8417 and lot numbers 2130077, 2130313, 2130630, 2130945, or 2131091 on the tray. The UDI code 00849233016804 is also associated with this recall.
Identify the catalog number and lot numbers on the tray to confirm if it is recalled.
The recall is due to uncertainty about the adequacy of validation for the test methods used to manufacture the drug products.
Lot numbers 2130077, 2130313, 2130630, 2130945, and 2131091 are affected.
Check for the catalog number 8417 and the specific lot numbers listed in the recall notice.
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-1159-2022 — Busse Hospital Disposables Busse Hospital Disposables Hello, I own a Busse Hospital Disposables that is covered by recall Z-1159-2022 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.
