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.
Reported: November 23, 2016 Initiated: October 26, 2016 #Z-0580-2017
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.
Details
- Recalling Firm
- Atrium Medical Corporation
- Units Affected
- 4836 cases (10/cs)
- Distribution
- Worldwide Distribution -- USA, Australia, Austria, Belgium, Canada, Costa Rica, Dominican Republic, Ecuador, Finland, France, Germany, Honduras, Hong Kong, Ireland, Jamaica, Kuwait, Mexico, Netherlands, New Zealand, Panama, Peru, Portugal, Puerto Rico, Qatar, Reunion, Romania, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and Venezuela.
- Location
- Hudson, NH
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Atrium Medical Corporation. Units affected: 4836 cases (10/cs).
Why was this product recalled? ▼
Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 23, 2016. Severity: Moderate. Recall number: Z-0580-2017.
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