Busse Hospital Disposables recalls SS 4.5MM Pellet Insertion Tray with Large Gloves (Catalog B1363R1) due to uncertainty in drug manufacturing test validation. 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 a specific pellet insertion tray with large gloves because the drug products in their convenience kits may not have been properly validated during manufacturing. This could affect the safety and effectiveness of the drug products.
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 mean the drugs might not be safe or effective when used as intended.
Healthcare professionals using the recalled pellet insertion trays with large gloves for drug administration are most at risk. Patients receiving these drug products could be affected if the trays are used without proper validation.
Check for the catalog number B1363R1 on the tray. Lot numbers 2110127 and 2110269 are affected. The unique device identifier (UDI) 00849233006515 is also associated with this recall.
Look for the catalog number B1363R1, lot numbers 2110127 or 2110269, or UDI 00849233006515 on the tray.
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.
Check the product details for the catalog number B1363R1, lot numbers 2110127 or 2110269, or UDI 00849233006515. If you have these, contact Busse Hospital Disposables for further instructions.
The recall is due to uncertainty in the manufacturing test validation, not a direct risk of injury. 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-1188-2022 — Busse Hospital Disposables Busse Hospital Disposables Hello, I own a Busse Hospital Disposables that is covered by recall Z-1188-2022 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.
