Z-1194-2018 Class II Terminated
FDA device recall Z-1194-2018 was initiated by Arrow International Inc on December 15, 2017 and is designated Class II. Reason for recall: Certain lots of peripheral catheter systems may be missing the safety latch, intended to minimize the risk of sharps injuries. The recall status is terminated (terminated July 18, 2019). Affected quantity: 305.
Recall Details
- Product Type
- Devices
- Report Date
- April 4, 2018
- Initiation Date
- December 15, 2017
- Termination Date
- July 18, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 305
Product Description
ARROW ENDURANCE" Extended Dwell Peripheral Catheter System, Catalog Numbers: EDC-00820 & EDC-00820-B
Reason for Recall
Certain lots of peripheral catheter systems may be missing the safety latch, intended to minimize the risk of sharps injuries.
Distribution Pattern
Distributed in the following U.S. states: CO, FL, IL, NC, PA, SC, and TX.
Code Information
Catalog Number: EDC-00820, Lot: 14X17C0039 (Expires February 2019); Catalog Number: EDC-00820-B, Lot: 13F17F0120 (Expires May 2019)