Abbott Vascular Inc: 20/30 Priority Pack Kit/.115 RHV, REF: 1000186-115, used for cardiovascular procedures.

Hazard

Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.

Details from the source

Reason for recall: Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism. Distribution: US: IA, MD, DC, IN, CA, NV, TX, CT, GA, MS, NY, OH, FL, NC, MI, KY, PA, VA, IL, OK, TN, UT, WA, WI, MT, OR, LA, HI, NE, AR, MO, MA, KS, ID, AL, AZ, PR, CO, SC. OUS: IN, KR, SG, TH, VN, AR, BR, CA, CO, PA, UY, BE, CZ, DE, ES, FR, GB, IT, PT, RE, SE, SK, TM, JP. Quantity: 4,975 Lot/code info: UDI-DI: 08717648015274, Lots: 60564920, 60564933, 60566431, 60566432, 60566433, 60566667

UPC codes

08717648015274

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.