Busse Hospital Disposables recalls 18G Single Shot Epidural Trays (Catalog 813: 2031049, 2131128) due to uncertain drug validation methods. Consumers should contact for 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 specific 18G Single Shot Epidural Trays because drug manufacturing validation methods are uncertain. This could affect patient safety during medical procedures.
The recall is due to uncertainty about whether the drug manufacturing validation methods were adequate. This could lead to potential safety issues during medical procedures if the drug products are not properly validated.
Healthcare professionals using these trays for epidural procedures are most at risk. Patients receiving epidural treatments using recalled trays may be affected.
Check for Catalog Number 8139R2 on the tray. Lot Numbers 2031049 and 2131128 are affected. The UDI code 00849233015890 identifies the recalled product.
Reach out to Busse Hospital Disposables for specific recall details and instructions.
The recall is due to uncertainty about the adequacy of the validation methods used to manufacture the drug products.
Contact Busse Hospital Disposables for specific instructions on how to handle the recalled product.
The recall is related to potential safety issues due to uncertain drug validation methods, but specific risks are not detailed in the 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-1174-2022 — Busse Hospital Disposables Busse Hospital Disposables Hello, I own a Busse Hospital Disposables that is covered by recall Z-1174-2022 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.
