FDA-Device2018-01-03Class I
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.
Sterilmed Inc
Hazard
Inadequate seal due to lack of adhesive glue
Sold states
US Nationwide distribution in the states of AR, CO, FL, MI, OH, TX, and WA.
Affected count
112 devices
Manufactured in
5010 Cheshire Pkwy N Ste 2, N/A, Minneapolis, MN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0213-2018Don't want to check this manually?
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