Recall Z-0922-2022— Abbott Vascular

Name: FDA recall Z-0922-2022
Creator: U.S. Food and Drug Administration
Published: 2022-03-11

Class II · Ongoing

Class II FDA medical device recall by Abbott Vascular, initiated 2022-03-11. It names one FDA 510(k) clearance: K961471. Product: 20/30 Priority Pack Accessory Kit/.096 RHV - REF 1000186 WPL2122270-01 (2019-03-01) 20/30 Priority Pack w/.115 RHV - REF 1000186-115 WPL2122270-02 (2019-03-01). Reason: Due to an increase in complaint trend for leaks and intermittent/loose connections..

Recalling firm: Abbott Vascular
Classification: Class II
Status: Ongoing
Initiated: 2022-03-11
Firm location: Temecula, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K961471 — INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACK (WITH THE .096 OR .115 ROTATING HEMOSTATIC VALVE)Advanced Cardiovascular Systems, Inc.·cleared 1996-05-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

20/30 Priority Pack Accessory Kit/.096 RHV - REF 1000186 WPL2122270-01 (2019-03-01) 20/30 Priority Pack w/.115 RHV - REF 1000186-115 WPL2122270-02 (2019-03-01)

Reason for recall

Due to an increase in complaint trend for leaks and intermittent/loose connections.

Data sourced from openFDA. This site is unofficial and independent of the FDA.