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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,
Recalled January 3, 2018 · FDA recall Z-0213-2018 · Sterilmed
Hazard
Inadequate seal due to lack of adhesive glue · FDA Class I
Units
112 devices
Sold at
US Nationwide distribution in the states of AR, CO, FL, MI, OH, TX, and WA.
Description
Inadequate seal due to lack of adhesive glue
Product
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.
Manufacturer(s)
Sterilmed Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →