FDA Enforcement
Class II
Terminated
Atrium PVC 10 Fr Straight Thoracic Catheter Code Number: 8010
Recall: Z-1222-2017
·
Reported February 22, 2017
Enforcement
- Recall Number
- Z-1222-2017
- Event ID
- 76138
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Atrium Medical Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 22, 2017
- Initiation Date
- January 20, 2017
- Classification Date
- February 16, 2017
- Termination Date
- November 3, 2020
- Address
- 5 Wentworth Dr, N/A, Hudson, NH, 03051-4929, United States
Description
Atrium PVC 10 Fr Straight Thoracic Catheter Code Number: 8010
Reason
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)
Code Info
All Lot Numbers With Expiration Date Prior To December 2019
Distribution
Nationwide
Quantity
1394 cases (10/case)