Sterilmed Inc recalls St. Jude Medical. Agilis NxT Steerable Introducer: B1-Directional, Medium Curl 22.4 mm, 71 cm, 6.5 F ID; Dilator: 94 cm…

Recall date

June 2, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0213-2018

FDA classification

Class I

Brand / firm

Sterilmed Inc

Sold / distributed

US Nationwide distribution in the states of AR, CO, FL, MI, OH, TX, and WA.

Why it was recalled

Inadequate seal due to lack of adhesive glue

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

St. Jude Medical. Agilis NxT Steerable Introducer: B1-Directional, Medium Curl 22.4 mm, 71 cm, 6.5 F ID; Dilator: 94 cm, 8.5 F; Super Stiff, Guidewire: 180 cm, 0.032". Reprocessed device for single use only, sterile. Product Usage: The reprocessed steerable introducer sheaths are indicated when introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.