Recall Z-0731-2025
Abbott Vascular Inc · initiated November 6, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
20/30 Priority Pack Accessory Kit/.096 RHV, REF: 1000186, or use during vascular procedures in conjunction with interventional and / or diagnostic devices (e.g., balloon dilatation catheters, atherectomy devices, stent delivery systems, intravascular ultrasound devices).
Codes / lots: UDI-DI: 08717648013614, Lots: 60538750, 60538751, 60539113, 60545329
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.
FDA-determined cause: Component change control
Action taken
On 11/6/2024, recall notices were distributed to customers asking them to take the following actions: 1) Stop using affected devices. 2) Complete and return the acknowledgement form. 3) Return unused devices to the firm. 4) Share this notification with relevant personnel in your organization. 5) If you have further distributed/transferred the affected products, notify those customers. If you have any questions contact firm customer service at 800-227-9902
Details
- Recall number
- Z-0731-2025
- Initiated
- November 6, 2024
- Posted by FDA
- December 20, 2024
- Product code
- MAV – Syringe, Balloon Inflation
- Quantity
- 3,673
- 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.
- Recalling firm
- Abbott Vascular Inc, Temecula, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0730-2025 Class II | 20/30 INDEFLATOR, REF: 1000184, for use during cardiovascular procedures in conjunction…Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer… | 11/06/2024Open, Classified |
| Z-0732-2025 Class II | 20/30 Priority Pack Accessory Kit w/Copilot, REF: 1003327, used for cardiovascular…Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer… | 11/06/2024Open, Classified |
| Z-0733-2025 Class II | 20/30 Priority Pack Kit/.115 RHV, REF: 1000186-115, used for cardiovascular procedures.Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer… | 11/06/2024Open, Classified |