Recall Z-0580-2017— Atrium Medical Corporation
Class II · Terminated
Class II FDA medical device recall by Atrium Medical Corporation, initiated 2016-10-26, terminated 2018-10-09. It names one FDA 510(k) clearance: K831931. Product: Atrium Medical 20 Fr Trocar catheter, sterile Model Number: 8420 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.. Reason: Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains..
- Recalling firm
- Atrium Medical Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-10-26
- Terminated
- 2018-10-09
- Firm location
- Hudson, NH, 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
Atrium Medical 20 Fr Trocar catheter, sterile Model Number: 8420 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.
Reason for recall
Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.
Data sourced from openFDA. This site is unofficial and independent of the FDA.