Busse Hospital Disposables recalls 3.2MM Pellet Insertion Trays (Catalog B9743) due to drug safety concerns from manufacturing validation uncertainty. Affected units include specific lot numbers.
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 3.2 million pellet insertion trays (Catalog B9743) because the drug products inside may not be manufactured safely due to uncertain test validation. This could affect patients using these trays for medical procedures.
The drug products in these trays were made using test methods that weren't fully validated, which could mean the drugs aren't safe for use. This uncertainty affects the reliability of the medication delivery.
Healthcare facilities and medical professionals who use these trays for procedures are most at risk. Patients using the trays for drug administration may also be affected.
Check for Catalog Number B9743 on the tray. Affected units include Lot Numbers 2031128, 2130202, and 2131304. The tray has a unique identifier (UDI) starting with 00849233011649.
Look for Catalog Number B9743 and Lot Numbers 2031128, 2130202, or 2131304 on the tray.
The drug products in these trays may not be manufactured safely due to uncertain test validation methods.
Check for Catalog Number B9743 and Lot Numbers 2031128, 2130202, or 2131304 on the tray.
The recall record does not specify a remedy, so contact Busse Hospital Disposables for guidance.
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-1203-2022 — Busse Hospital Disposables Busse Hospital Disposables Hello, I own a Busse Hospital Disposables that is covered by recall Z-1203-2022 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.
