FDAFDA · Food and drugs·Recall number Z-1221-2017
Atrium PVC 8 Fr Straight Thoracic Catheter Code Number: 8008
Published February 22, 2017 · Recall initiated: January 20, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Labeling icon depicts a catheter having six (6) eyelets; however the correct number of eyelets on the 8 Fr and 10 Fr thoracic catheters is two (2)
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Atrium Medical Corporation
- Distributor
- Nationwide
- Lot
- All Lot Numbers With Expiration Date Prior To December 2019
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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