FDA recall Z-0733-2025

Product

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

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.

Key facts

Status

Ongoing

Initiation date

2024-11-06

Report date

2025-01-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Temecula, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0733-2025