Busse Hospital Disposables recalls cervical tray catalog 376:1213S lot numbers due to uncertain drug test validation. Affected units may have safety risks.
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 cervical trays with catalog number 3765R2 because the drug products inside may not be made safely due to uncertain test validation. This could affect users if the product is used incorrectly.
The drug products in the cervical tray kits were made using test methods that aren't fully validated. This uncertainty means the drugs might not be safe for use, potentially causing harm if used incorrectly.
Healthcare professionals using the cervical tray kits are most at risk. Patients receiving these kits may also be affected if the product is used improperly.
Check for catalog number 3765R2 on the cervical tray. Lot numbers 2031213S, 2130221S, and UDI 00849233015203 are also indicators of affected units.
Look for catalog number 3765R2, lot numbers 2031213S or 2130221S, or UDI 00849233015203 on the cervical tray.
The drug products in the cervical tray kits were made using test methods that aren't fully validated, which could affect safety.
The recall record does not specify a remedy, so check the product details and contact Busse Hospital Disposables for further instructions.
Yes, lot numbers 2031213S and 2130221S are affected, as well as the UDI 00849233015203.
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-1168-2022 — Busse Hospital Disposables Busse Hospital Disposables Hello, I own a Busse Hospital Disposables that is covered by recall Z-1168-2022 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.
