medical Class II Updated 2021-07-07

Edwards Lifesciences, LLC recalls Edwards TruWave (30 cc)/VAMP Jr/52 in (132 cm) Kit, REF: PXV

Recalled Product

Edwards TruWave (30 cc)/VAMP Jr/52 in (132 cm) Kit, REF: PXVJ0711, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 07460691954489


Hazard / Issue

There is a potential that the pressure tubing may detach from the blood sampling system

Issued by

FDA

Affected States: AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, SD, TX, UT, VA, WA, WI, WV
Lot/Code Info: Lot #s: 63470654, 63505217 and 63592430
View official government recall

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