Busse Hospital Disposables recalls SS 3.5MM Diamond Tip Trocar (Catalog B1555) due to uncertainty in drug manufacturing validation. Affected units include specific lot numbers. 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 3.5MM Diamond Tip Trocar gloves (Catalog B155: B1555) because the drug products they contain may not be manufactured with validated test methods. This could affect safety if used in medical procedures.
The recall is due to uncertainty about whether the drug products in these gloves were manufactured using validated test methods. This could mean the drugs might not be safe for medical use, potentially causing harm during procedures.
Healthcare professionals using these gloves for medical procedures are most at risk. Patients receiving treatments with these gloves may be affected if the drug products are unsafe.
Check for Catalog Number B1555 on the product. Lot numbers 2110053 or 2110115 are affected. The UDI code 00849233005402 identifies the specific product.
Reach out to Busse Hospital Disposables for specific instructions on handling the recalled product.
The recall is due to uncertainty about the adequacy of test methods used to manufacture the drug products, which could affect safety.
Contact Busse Hospital Disposables directly for specific instructions on handling the recalled product.
Yes, lot numbers 2110053 and 2110115 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-1191-2022 — Busse Hospital Disposables Busse Hospital Disposables Hello, I own a Busse Hospital Disposables that is covered by recall Z-1191-2022 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.
