FDAFDA · Food and drugs·Recall number Z-1804-2012
Churchill Medical Systems, Inc. A VYGON Company PICC INSERTION TRAY Kit Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens
Published June 20, 2012 · Recall initiated: May 11, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Vygon Corporation
- Distributor
- Nationwide Distribution including AZ, CA, DE, FL, IL, IN, IA, KS, KY, MD, MA, MI, MN, MO, NJ, NY, OH, PA, UT, VA, WA, WV, and WI.
- Lot
- Product Code AMS-8280CP-4 -- lots 10K16, 10L20, 11A78, 11B24, 11B16, 11C70, and 11D14.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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