Z-2329-2017 Class II Terminated
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) Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr., Introducer Catheter 2) Arrow PSI Kit
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-09803-WBH1, ASK-09903-KH, CDC-09803-1A Device Listing E433883