Recall Z-0895-2022— Abbott

Name: FDA recall Z-0895-2022
Creator: U.S. Food and Drug Administration
Published: 2021-11-09

Class II · Terminated

Class II FDA medical device recall by Abbott, initiated 2021-11-09, terminated 2024-08-07. It names one FDA 510(k) clearance: K212026. Product: Amplatzer Steerable Delivery Sheath. Reason: Instructions for use were updated..

Recalling firm: Abbott
Classification: Class II
Status: Terminated
Initiated: 2021-11-09
Terminated: 2024-08-07
Firm location: Plymouth, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K212026 — Amplatzer Steerable Delivery SheathABBOTT MEDICAL·cleared 2021-09-27

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

Amplatzer Steerable Delivery Sheath

Reason for recall

Instructions for use were updated.

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