Z-2327-2017 Class II Terminated
FDA device recall Z-2327-2017 was initiated by Arrow International Inc on May 9, 2017 and is designated Class II. Reason for recall: Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility. The recall status is terminated (terminated September 17, 2018). Affected quantity: 27, 485 distributed in the U.S, 4,371 distributed Internationally.
Recall Details
- Product Type
- Devices
- Report Date
- June 21, 2017
- Initiation Date
- May 9, 2017
- Termination Date
- September 17, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 27, 485 distributed in the U.S, 4,371 distributed Internationally
Product Description
Arterial Catheterization Kit, Arterial Line Kit with Sharps Safety Features wire, guide, catheter The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels
Reason for Recall
Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
Distribution Pattern
Worldwide Distribution - US (nationwide) and Canada
Code Information
Material number: ASK-04018-CC, ASK-04510-HUM, ASK-04550-UHC, Device Listing D025180