Busse Hospital Disposables recalls Epidural Tray Catalog 1307 with lot numbers 2131254 and UDI 00849233003668 due to uncertainty in drug manufacturing validation test methods.
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 Epidural Tray Catalog 1307 because drug products in the convenience kits may have manufacturing validation issues. This could affect medical safety during epidural procedures.
The drug products in the convenience kits were manufactured by Professional Disposables International (PDI) but there is uncertainty about the validation of test methods used to ensure quality. This could lead to potential safety issues during medical procedures.
Healthcare professionals using the Epidural Tray Catalog 1307 with specific lot numbers and UDI are likely affected. Patients receiving epidural procedures using this product may be at risk.
Check for Epidural Tray Catalog 1307 with lot number 2131254 or Unique Device Identifier (UDI) 00849233003668. The product was sold by Busse Hospital Disposables, Inc.
Identify if your Epidural Tray Catalog 1307 has lot number 2131254 or UDI 00849233003668.
The drug products in the convenience kits were manufactured by Professional Disposables International (PDI) but there is uncertainty about the validation of test methods used to ensure quality.
The recall record does not specify a remedy, so check product details to see if it matches the recalled lot numbers or UDI.
The recall record does not describe a specific hazard mechanism that could cause serious injury, so the risk level is unknown.
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-1153-2022 — Busse Hospital Disposables Busse Hospital Disposables Hello, I own a Busse Hospital Disposables that is covered by recall Z-1153-2022 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.
