Busse Hospital Disposables recalls specific pellet insertion trays with medium gloves due to uncertain drug testing validation. Affected units have catalog number B1351 and listed lot numbers. Consumers should check their product 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 certain 3.2MM Pellet Insertion Trays with Medium Gloves (catalog B135: B1351) because drug testing validation may be inadequate. This could affect the safety of the drug products in these kits.
The recall is due to uncertainty about whether the drug testing methods used to manufacture the products were validated properly. This could mean the drug products might not be safe for use.
Healthcare professionals using these specific trays with medium gloves for drug administration are most at risk. Patients receiving medications through these kits may also be affected.
Check for catalog number B1351 on the tray. Lot numbers 2110082, 2110174, 2110254, and 2110221 are affected. The unique device identifier (UDI) 00849233004733 is also associated with this recall.
Look for catalog number B1351 and lot numbers 2110082, 2110174, 2110254, or 2110221 on the tray.
The recall is due to uncertainty about the adequacy of the validation of the test methods used to manufacture the drug products.
Check the product details to see if it matches the recalled items. If it does, contact Busse Hospital Disposables for further instructions.
The recall indicates potential safety concerns due to uncertain drug testing validation, but no specific injury risks are described.
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-1180-2022 — Busse Hospital Disposables Busse Hospital Disposables Hello, I own a Busse Hospital Disposables that is covered by recall Z-1180-2022 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.
