The Iodine Prep Pads within the Vygon IV Start Convenience Kits, had stability samples that were not meeting iodine assay level requirements to support the 36 month expiration date. All kits containing the affected pads were recalled.
The Iodine Prep Pads within the Vygon IV Start Convenience Kits, had stability samples that were not meeting iodine assay level requirements to support the 36 month expiration date. All kits containing the affected pads were recalled.
We break every recall down into plain English — this one’s still on our list. Until our write-up is ready, the official FDA hazard and remedy below have the full, accurate details.
We’ve drafted a message you can send Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. to request your refund or repair — edit it as you like.
Subject: Recall Z-0933-2018 — Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. Vygon MFG, Inc., dba/ Churchill Medical Syste Hello, I own a Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. recalls Vygon IV Start Convenience Kits; Product Codes AMS-623T and AMS-626TGSLF. Kit used when administering IV during that is covered by recall Z-0933-2018 from Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.. 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.
