FDA Enforcement
Class II
Terminated
Arterial Line Catheterization Kit with Sharps Safety Features Permits access to the peripheral arterial circulation or to other small vessels.
Recall: Z-2740-2016
·
Reported September 14, 2016
Enforcement
- Recall Number
- Z-2740-2016
- Event ID
- 74986
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Arrow International Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 14, 2016
- Initiation Date
- August 8, 2016
- Classification Date
- September 7, 2016
- Termination Date
- August 22, 2017
- Address
- 2400 Bernville Rd, Reading, PA, 19605-9607, United States
Description
Arterial Line Catheterization Kit with Sharps Safety Features Permits access to the peripheral arterial circulation or to other small vessels.
Reason
Shipping carton labeling error.
Code Info
Device Listing # D025180
Distribution
Nationwide Distribution to OH, IN, TN, NC, and KY.
Quantity
690 kits