Busse Hospital Disposables recalls SS :4.5MM Pellet Insertion Tray (Catalog B1363) due to uncertain drug test validation. Affected units have specific lot numbers and UDI codes.
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 their SS 4.5MM Pellet Insertion Tray with Large Gloves (Catalog B1363) because the drug products in the convenience kits may not have been properly validated during manufacturing. This could affect patient safety if the drug products are used incorrectly.
The drug products in the convenience kits were manufactured by Professional Disposables International (PDI) but the validation of the test methods used to create these drugs is uncertain. This uncertainty could lead to improper drug effectiveness or safety.
Healthcare professionals using the tray with the specific lot numbers and UDI codes listed in the recall. Patients receiving the drug products in these kits may be at risk if the products are not properly validated.
Check for the catalog number B1363 and lot numbers 2010337 on the tray. The unique device identifier (UDI) 00849233006515 is also associated with this product.
Look for the catalog number B1363 and lot number 2010337 on the tray.
The drug products in the convenience kits may not have been properly validated during manufacturing, which could affect patient safety.
The recall record does not specify a remedy, so check the product details to see if it matches the listed catalog number and lot numbers.
The recall record does not describe a specific hazard mechanism that would cause serious injury, so the risk level is unknown.
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-1187-2022 — Busse Hospital Disposables Busse Hospital Disposables Hello, I own a Busse Hospital Disposables that is covered by recall Z-1187-2022 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.
