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.
FDA Recall Z-0213-2018 · Posted 2017-12-29
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Recalling FirmSterilmed Inc
Recall StatusTerminated
Product CodeDYB
Date Initiated2017-06-02
Date Terminated2019-07-29
Product Quantity112 devices
Reason for Recall
Inadequate seal due to lack of adhesive glue
Firm Action
Sterilmed sent an Urgent Medical Device Recall letter dated June 12, 2017 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory to determine if affected products are on hand, complete and return the Business Reply Form, share information with appropriate staff in facility, attach copy of this notification to quarantined product, and return affected product to Sterilmed. For questions contact Sterilmed's Customer Care Team at 888-541-0078.
Root Cause
Process control
Distribution Pattern
US Nationwide distribution in the states of AR, CO, FL, MI, OH, TX, and WA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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