Busse Hospital Disposables recalls Single Shot Epidural Trays (Catalog 1165) with specific lot numbers due to uncertainty in drug manufacturing test validation. Affected units may have inadequate quality control.
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 1165 because the drug products inside may not have been properly validated during manufacturing. This could affect the safety and effectiveness of the medical device.
The recall is due to uncertainty about whether the test methods used to validate the drug products were adequate during manufacturing. This could mean the products might not meet safety standards, potentially affecting medical outcomes.
Healthcare professionals using the Single Shot Epidural Tray Catalog 1165 are likely affected. Patients receiving epidural anesthesia through this device may be at risk if the product has manufacturing issues.
Check for the product name 'Single Shot Epidural Tray' with Catalog number 1165. Affected units have specific lot numbers: 2130290 and 2131184, and a unique device identifier (UDI) of 00849233006485.
Identify the product by checking for Catalog number 1165, lot numbers 2130290 or 2131184, and UDI 00849233006485.
The recall is due to uncertainty about the adequacy of test methods used to validate the drug products during manufacturing.
The official notice does not specify a remedy, so check with Busse Hospital Disposables for further instructions.
Lot numbers 2130290 and 2131184 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-1151-2022 — Busse Hospital Disposables Busse Hospital Disposables Hello, I own a Busse Hospital Disposables that is covered by recall Z-1151-2022 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.
