Z-2328-2017 Class II Terminated
FDA device recall Z-2328-2017 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 units distributed in U.S., 4,371 units 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 units distributed in U.S., 4,371 units distributed internationally
Product Description
Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, Catheter, Percutaneous The Arrow Single-Lumen Catheter permits venous access to the central circulation
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-04301-WBH Device Listing D040650