Busse Hospital Disposables recalls SS 4.5MM Diamond Tip Trocar with Large Gloves (Catalog B1559) due to drug safety concerns 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 SS 4:5MM Diamond Tip Trocar with Large Gloves (Catalog B1559) because the drug products in these kits may not be manufactured safely due to uncertain test validation methods. This affects medical professionals using these devices for procedures.
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.
Medical professionals who use these trocars for procedures are likely affected. Patients receiving treatments with these devices could be at risk if the drug products are unsafe.
Check for the catalog number B1559 on the trocar packaging. Lot numbers 2110052 and UDI 00849233005419 are also associated with this recall.
Look for catalog number B1559, lot number 2110052, or UDI 00849233005419 on the trocar packaging.
The drug products in these kits may not be manufactured safely due to uncertain validation of the test methods used during production.
Check the product details for the catalog number B1559, lot number 2110052, or UDI 00849233005419. If it matches, contact Busse Hospital Disposables for further instructions.
The recall is due to potential safety concerns with the drug products, not the trocar itself. The official notice does not specify injury risks.
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-1192-2022 — Busse Hospital Disposables Busse Hospital Disposables Hello, I own a Busse Hospital Disposables that is covered by recall Z-1192-2022 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.
