Busse Hospital Disposables recalls 3.2MM Pellet Insertion Trays (Catalog B1144) due to uncertain drug testing validation. Affected units include specific lot numbers. Consumers should check their product 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 3.2 million pellet insertion trays (Catalog Number B1144) because the drug products inside may not have been properly validated during manufacturing. This recall is due to uncertainty about the test methods used to ensure the drug products' safety and quality.
The recall is triggered by uncertainty about the adequacy of the test methods used to validate the drug products. This means the drug products may not meet safety and quality standards as required by regulatory authorities.
Healthcare professionals and patients using the pellet insertion trays with Busse Convenience kits that contain the recalled drug products. Those who have the specific lot numbers listed in the recall are most at risk.
Check for the Catalog Number B1144 on the tray. Look for Lot Numbers: 2010270, 2110081, 2110173, or 2110220. The Unique Device Identifier (UDI) is 00849233003835.
Identify the Catalog Number B1144 and Lot Numbers listed in the recall notice to confirm if your tray is affected.
The recall is due to uncertainty about the adequacy of the test methods used to validate the drug products, which may affect their safety and quality.
The recall record does not specify a remedy or action steps beyond checking product details. Contact Busse Hospital Disposables for further guidance.
Yes, the affected lot numbers are 2010270, 2110081, 2110173, and 2110220.
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-1179-2022 — Busse Hospital Disposables Busse Hospital Disposables Hello, I own a Busse Hospital Disposables that is covered by recall Z-1179-2022 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.
