Busse Hospital Disposables recalls single shot epidural trays with catalog number 6797R2 due to uncertain drug test validation. Affected units include specific lot numbers. Consumers should contact the manufacturer 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 single shot epidural trays with catalog number 6797R2 because the drug products inside may not be manufactured safely. This could affect medical procedures if used improperly.
The drug products in the trays were made using test methods that aren't fully validated. This uncertainty means the drugs might not be safe for medical use, potentially causing harm during procedures.
Healthcare professionals using these trays for epidural procedures are most at risk. Patients receiving epidural treatments with the recalled trays may be affected.
Check for catalog number 6797R2 on the tray. Affected units include lot numbers 2030835, 2031025, 2031217, and 2130006. The UDI code 00849233014657 is also associated with these units.
Look for catalog number 6797R2 and lot numbers 2030835, 2031025, 2031217, or 2130006 on the tray.
The drug products in the trays were manufactured using test methods that aren't fully validated, raising safety concerns.
The recall record does not specify a remedy, so contact Busse Hospital Disposables directly for guidance.
Lot numbers 2030835, 2031025, 2031217, and 2130006 are affected.
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-1172-2022 — Busse Hospital Disposables Busse Hospital Disposables Hello, I own a Busse Hospital Disposables that is covered by recall Z-1172-2022 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.
