regard Clinical Packaging Solutions recalls convenience kits with item 830110002 (IV01121B) due to potential inadequate validation of test methods in manufacturing. Lot numbers 89889, 90446, and 90641 expired 5/12/2022.
A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the validation of test methods used in its manufacture.
regard Clinical Packaging Solutions is recalling convenience kits containing IV Start Kits with item number 830110002 (IV01121B). The recall is due to potential inadequacy in the validation of test methods used during manufacturing, which could affect the kit's reliability.
The recall states that the drug kit component may have inadequate validation of test methods used in its manufacture. This could lead to potential issues with the kit's reliability, though the exact risk is not specified in the recall notice.
Healthcare professionals using these kits for IV starts during labor birth procedures are likely affected. The risk is highest for those using the specific lot numbers listed in the recall.
Check for the item number 830110002 (IV01121B) on the kit. The recall includes lot numbers 89889, 90446, and 90641, all expiring 5/12/2022.
Look for the item number 830110002 (IV01121B) and lot numbers 89889, 90446, or 90641 on the kit.
The recall is due to potential inadequacy in the validation of test methods used during manufacturing, which could affect the kit's reliability.
Lot numbers 89889, 90446, and 90641, all expiring 5/12/2022.
The recall does not specify a remedy, so there is no instruction to stop using the kits. However, you should check if your kit matches the affected details.
We’ve drafted a message you can send regard Clinical Packaging Solutions to request your refund or repair — edit it as you like.
Subject: Recall Z-1006-2022 — regard Clinical Packaging Solutions regard Clinical Packaging Solutions Hello, I own a regard Clinical Packaging Solutions that is covered by recall Z-1006-2022 from regard Clinical Packaging Solutions. 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.
