Busse Hospital Disposables recalls Procedural Accessory Kit (Catalog 9665R2) due to uncertain drug validation methods. Affected units include specific lot numbers. Consumers should contact the manufacturer for 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 a specific procedural accessory kit (Catalog Number 9665R2) because the drug products inside may not have been properly validated during manufacturing. This could affect the safety and effectiveness of the kit's contents.
The kit contains drug products that were manufactured using test methods whose validation adequacy is uncertain. This means the drugs might not meet safety and quality standards, potentially affecting their effectiveness or safety during medical procedures.
Healthcare professionals and facilities using the Procedural Accessory Kit with Catalog Number 9665R2 are likely affected. Those using the kit for medical procedures may be at risk if the drug products are not properly validated.
Check for Catalog Number 9665R2 on the kit. Affected units include Lot Numbers 2031038 and UDI 00860000210461. The kit is sold by Busse Hospital Disposables.
Reach out to Busse Hospital Disposables for specific instructions on handling the recalled kit.
The kit contains drug products that were manufactured using test methods whose validation adequacy is uncertain, potentially affecting safety and effectiveness.
Contact Busse Hospital Disposables directly for specific instructions on handling the recalled kit.
Yes, Lot Number 2031038 and UDI 00860000210461 are affected.
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-1178-2022 — Busse Hospital Disposables Busse Hospital Disposables Hello, I own a Busse Hospital Disposables that is covered by recall Z-1178-2022 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.
