FDA Medical devices recall ·
20/30 Priority Pack Accessory Kit w/Copilot recall
- Recall number
- Z-0732-2025
- Date
- (initiated November 6, 2024)
- Company / brand
- Abbott Vascular Inc
26531 Ynez Rd, Temecula, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 23,407
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
20/30 Priority Pack Accessory Kit w/Copilot, REF: 1003327, used for cardiovascular procedures.
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 08717648013973, Lots: 60516923, 60553232, 60553233, 60556003, 60556008, 60556009, 60556011, 60556012, 60556014, 60557297, 60559370, 60559371, 60559374, 60559375, 60559376, 60561751, 60561752, 60561753, 60561754, 60561755
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.
States: Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Michigan Missouri Mississippi Montana North Carolina Nebraska Nevada New York Ohio Oklahoma Oregon Pennsylvania Puerto Rico South Carolina Tennessee Texas Utah Virginia Washington Wisconsin
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0732-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.