Busse Hospital Disposables recalls SS 4.5MM Pellet Insert: Catalog B9807 with lot 2031228. Drug safety concerns due to test validation uncertainty. 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 Pellet Insertion Trays with catalog number B9807 and lot number 2031228 due to potential drug safety issues from uncertain test validation during manufacturing. This recall affects medical devices used in drug administration.
The recall is due to uncertainty about the validation of test methods used to manufacture the drug products. This could mean the drug products might not be safe or effective as intended, though the exact risk is not specified.
Healthcare professionals and patients using the SS 4.5MM Pellet Insertion Tray for drug administration are likely affected. Those with the specific catalog number and lot number are at risk.
Check for catalog number B9807 and lot number 2031228 on the SS 4.5MM Pellet Insertion Tray. The product was sold with the UDI 00849233003552.
Reach out to Busse Hospital Disposables for specific instructions on handling the recalled product.
The recall is due to uncertainty about the validation of test methods used to manufacture the drug products, which could affect safety or effectiveness.
Contact Busse Hospital Disposables directly for specific instructions on handling the recalled product.
The recall indicates potential safety concerns, but the exact risk is not specified in the official notice.
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-1204-2022 — Busse Hospital Disposables Busse Hospital Disposables Hello, I own a Busse Hospital Disposables that is covered by recall Z-1204-2022 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.