Vygon recalls PICC insertion trays with potential friction holes that could compromise sterility. Affected units include specific lot numbers and product codes. Consumers should check their kit for the listed serial numbers.
Potential friction holes may affect the sterility of the product.
Vygon is recalling a PICC insertion tray convenience kit due to a risk that friction holes might compromise the product's sterility. This could lead to infections if the tray is used improperly.
Friction holes in the tray could create small openings that allow contaminants to enter the sterile product. This might increase the risk of infection during medical procedures if the tray is not properly sterilized.
Healthcare professionals using the PICC insertion tray kit for vascular procedures are most at risk. Patients receiving PICC treatments using this specific model may also be affected.
Check the product code AMS-7192CS-4 on the tray. Affected units have lot numbers 17I040D, 17I041D, 17J016D, 17I002D, 17J015D, or 17J018D.
Look for the product code AMS-7192CS-4 on the tray.
The recall is for potential sterility issues from friction holes, which could increase infection risk during medical procedures. However, the hazard is not severe enough to require immediate discontinuation.
Check the product code AMS-7192CS-4 and lot numbers 17I040D, 17I041D, 17J016D, 17I002D, 17J015D, or 17J018D.
The recall does not specify a remedy, so no action is required beyond checking if your product is affected.
We’ve drafted a message you can send Vygon to request your refund or repair — edit it as you like.
Subject: Recall Z-1640-2018 — Vygon Vygon Hello, I own a Vygon that is covered by recall Z-1640-2018 from Vygon. 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.
