FDA Enforcement
Class II
Terminated
Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device Listing D025180 Material ASK-04018-VUH Product Usage: The Arrow arterial catheterization device permits access to the peripheral arterial circulation.
Recall: Z-2202-2016
·
Reported July 20, 2016
Enforcement
- Recall Number
- Z-2202-2016
- Event ID
- 74489
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Arrow International Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 20, 2016
- Initiation Date
- June 2, 2016
- Classification Date
- July 12, 2016
- Termination Date
- August 21, 2017
- Address
- 2400 Bernville Rd, Reading, PA, 19605-9607, United States
Description
Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device Listing D025180 Material ASK-04018-VUH Product Usage: The Arrow arterial catheterization device permits access to the peripheral arterial circulation.
Reason
Labeling error. Some shipping cartons labeled as ASK-04018-VUH contained ASK-04020-VUH kits; and some shipping cartons labeled as ASK-04020-VUH contained ASK-04018-VUH kits.
Code Info
Lot/Batch Numbers: 23F14M0829, 23F14M0986
Distribution
US distribution in the states of TN and KY.
Quantity
50 units in total