medical Class II Updated 2021-07-07

Edwards Lifesciences, LLC recalls Edwards TruWave x 2 (3 cc)/VAMP Jr/54 in (136) Kit, REF: T4

Recalled Product

Edwards TruWave x 2 (3 cc)/VAMP Jr/54 in (136) Kit, REF: T443952B, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 57460691930174 ***Not Marketed within the US

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 # 63479666- Not Marketed within the US

View official government recall

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