Recall archive / FDA device enforcement
20/30 Priority Pack Kit/.115 RHV, REF: 1000186-115, used for cardiovascular procedures. — FDA record Z-0733-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 6, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 20/30 Priority Pack Kit/.115 RHV, REF: 1000186-115, used for cardiovascular procedures.
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- Abbott Vascular Inc
- Quantity
- 4,975
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0733-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI: 08717648015274, Lots: 60564920, 60564933, 60566431, 60566432, 60566433, 60566667 |
Match all identifying details in the current notice. A brand name alone is not enough.
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 below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- 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
- South Carolina
- Tennessee
- Texas
- Utah
- Virginia
- Washington
- Wisconsin
Dates in the source
- Report date
- Jan 1, 2025
- Recall initiation date
- Nov 6, 2024
- Center classification date
- Dec 20, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.