Busse Hospital Disposables recalls Cervical Tray Catalog 1089 with specific lot numbers due to uncertainty in drug product validation during manufacturing. Consumers should check their lot numbers to determine if affected.
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 Tray Catalog 1089 with specific lot numbers because the drug products in these kits may not have been properly validated during manufacturing. This could affect the safety and effectiveness of the products.
The recall is due to uncertainty about whether the test methods used to validate the drug products were adequate during manufacturing. This could mean the products might not work as intended or could be unsafe.
Users of Cervical Tray Catalog 1089 with the listed lot numbers are affected. Patients receiving these products for medical use are most at risk.
Check the lot numbers on your Cervical Tray Catalog 1089: 2030899, 2130011, 2130214, 2130789, 2130798, 2130898, 2131135. The UDI is 00849233000414.
Identify your Cervical Tray Catalog 1089 lot numbers from the list: 2030899, 2130011, 2130214, 2130789, 2130798, 2130898, 2131135.
Cervical Tray Catalog 1089 with specific lot numbers: 2030899, 2130011, 2130214, 2130789, 2130798, 2130898, 2131135.
The drug products in these kits may not have been properly validated during manufacturing due to uncertainty in test methods.
Check your lot numbers against the list provided. If affected, contact Busse Hospital Disposables for further instructions.
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-1149-2022 — Busse Hospital Disposables Busse Hospital Disposables Hello, I own a Busse Hospital Disposables that is covered by recall Z-1149-2022 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.
