Busse Hospital Disposables recalls 4.5MM Pellet Insert: Medium gloves with catalog number B1362 due to uncertain drug testing validation. Affected items include specific lot numbers and UDI.
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 4.5MM Pellet Insertion Trays with Medium Gloves (catalog number B1362) because the drug products in these kits may not have been properly validated during manufacturing. This could affect the safety and effectiveness of the medication.
The recall is due to uncertainty about whether the test methods used to validate the drug products were adequate during manufacturing. This could mean the medication might not work as intended or could be unsafe.
Healthcare professionals using these trays for medical procedures are most at risk. Patients receiving medication from these kits could be affected if the product is used without proper validation.
Check for catalog number B1362 on the tray. Lot numbers 2110098 and UDI 00849233004610 are associated with this recall.
Look for catalog number B1362, lot number 2110098, or UDI 00849233004610 on the tray.
The recall is due to uncertainty about the adequacy of test methods used to validate the drug products during manufacturing.
Check for catalog number B1362, lot number 2110098, or UDI 00849233004610. If you have these details, contact Busse Hospital Disposables for further instructions.
The recall is about potential drug safety concerns, not direct injury risks. The official notice does not specify injury risks.
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-1186-2022 — Busse Hospital Disposables Busse Hospital Disposables Hello, I own a Busse Hospital Disposables that is covered by recall Z-1186-2022 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
