Recall Z-1987-2013— Atrium Medical Corporation
Class II · Terminated
Class II FDA medical device recall by Atrium Medical Corporation, initiated 2013-07-16, terminated 2014-07-15. FDA's recall record names no specific 510(k) clearance for this event. Product: PleuraGuide Disposable Chest Tube Kit; Product codes: 17100, 17150, and 17200. Indicated to assist with the insertion of thoracic catheters.. Reason: Individual component's IFUs are not included with the kit..
- Recalling firm
- Atrium Medical Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-07-16
- Terminated
- 2014-07-15
- Firm location
- Hudson, NH, United States
Product description
PleuraGuide Disposable Chest Tube Kit; Product codes: 17100, 17150, and 17200. Indicated to assist with the insertion of thoracic catheters.
Reason for recall
Individual component's IFUs are not included with the kit.
Data sourced from openFDA. This site is unofficial and independent of the FDA.