Recall Z-0960-2019— Abbott Vascular

Name: FDA recall Z-0960-2019
Creator: U.S. Food and Drug Administration
Published: 2018-07-03

Class II · Terminated

Class II FDA medical device recall by Abbott Vascular, initiated 2018-07-03. It names one FDA 510(k) clearance: K962495. Product: PLUS 30 PRIORITY PACK Accessory Kit Product Usage: Is recommended for 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).. Reason: Incorrect expiration being entered for one lot..

Recalling firm: Abbott Vascular
Classification: Class II
Status: Terminated
Initiated: 2018-07-03
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 Accessory Kit Product Usage: Is recommended for 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).

Reason for recall

Incorrect expiration being entered for one lot.

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