Recall Z-0925-2022— Abbott Vascular

Name: FDA recall Z-0925-2022
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: K962495. Product: Plus 30 Priority Pack w/.096 RHV - REF 1000183 WPL2122277-01 (20-03-01) Plus 30 Priority Pack w/.115 RHV - REF 1000185-115 WPL2122279-01 (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

K962495 — INDEFLATOR PLUS 30/PLUS 30 PRIORITY PACK9WITH THE.096 OR.115 ROTATING HEMOSTATIC VALVE)Advanced Cardiovascular Systems, Inc.·cleared 1996-09-12

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

Plus 30 Priority Pack w/.096 RHV - REF 1000183 WPL2122277-01 (20-03-01) Plus 30 Priority Pack w/.115 RHV - REF 1000185-115 WPL2122279-01 (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.