Busse Hospital Disposables recalls SS :4.5MM Diamond Tip Trocar with Medium Gloves (Catalog B1560) due to uncertain drug test validation. Affected units include Lot 2110059 and UDI 00849233005426. 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 SS 4.5MM Diamond Tip Trocar with Medium Gloves (Catalog B1560) because drug test validation methods may not be adequate. This could affect the safety of the drug products in the kits.
The drug products in the kits were manufactured using test methods that may not have been validated properly. This uncertainty could lead to unsafe drug products if used in medical procedures.
Healthcare professionals using the trocar kits for medical procedures are most at risk. Patients receiving these kits may also be affected if the drug products are used incorrectly.
Check for Catalog Number B1560 on the product. Lot Numbers 2110059 and Unique Device Identifier (UDI) 00849233005426 are associated with this recall.
Look for Catalog Number B1560, Lot Number 2110059, or UDI 00849233005426 on the trocar kit.
The drug products in the kits were manufactured using test methods that may not have been validated properly, leading to uncertainty about their safety.
The official recall notice does not specify a remedy or action steps for affected products.
Check for Catalog Number B1560, Lot Number 2110059, or Unique Device Identifier (UDI) 00849233005426 on the trocar kit.
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-1193-2022 — Busse Hospital Disposables Busse Hospital Disposables Hello, I own a Busse Hospital Disposables that is covered by recall Z-1193-2022 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.