Z-2331-2017 Class II Terminated
FDA device recall Z-2331-2017 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
1) Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology is indicated for short-term or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media, and allows for central venous pressure monitoring
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-45552-RWJ4 Device Listing D213817