Busse Hospital Disposables recalls SS 3.5MM Diamond Tip Trocar Large Gloves (Catalog B1547) due to drug validation uncertainty. Affected lot numbers: 2110054, 2110116. No remedy specified in recall notice.
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 Large Gloves with catalog number B154: 2110054 and 2: 2110116. The recall is due to uncertainty about whether the drug manufacturing test methods were validated properly. This could affect patient safety if the drug products aren't made correctly.
The recall is for drug products made using swab/swabstick kits that may have unvalidated test methods. This uncertainty could mean the drugs aren't made correctly, potentially affecting patient safety during medical procedures.
Healthcare professionals using these gloves in medical settings are most at risk. Patients receiving treatments with these gloves may be affected if the drug products are not manufactured correctly.
Check for catalog number B1547 on the product. Lot numbers 2110054 and 2110116 are affected. The product is labeled as SS 3.5MM Diamond Tip Trocar Large Gloves.
Look for catalog number B1547 and lot numbers 2110054 or 2110116 on the product.
The recall is due to uncertainty about whether the drug manufacturing test methods were validated properly.
The recall notice does not specify a remedy, so no action is required beyond checking if you have the affected lot numbers.
The recall is for drug validation uncertainty, not a direct hazard like injury. The official notice does not describe a specific injury risk.
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-1190-2022 — Busse Hospital Disposables Busse Hospital Disposables Hello, I own a Busse Hospital Disposables that is covered by recall Z-1190-2022 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.
