Recall Z-0213-2018— Sterilmed Inc
Class I · Terminated
Class I FDA medical device recall by Sterilmed Inc, initiated 2017-06-02, terminated 2019-07-29. It names one FDA 510(k) clearance: K152090. 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.. Reason: Inadequate seal due to lack of adhesive glue.
- Recalling firm
- Sterilmed Inc
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2017-06-02
- Terminated
- 2019-07-29
- Firm location
- Minneapolis, MN, United States
510(k) clearances named in this recall
1 on FDA's recordK-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
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.
Reason for recall
Inadequate seal due to lack of adhesive glue
Data sourced from openFDA. This site is unofficial and independent of the FDA.