FDA recall Z-1194-2018

Arrow International Inc · Class II · device

Product

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

Distributed in the following U.S. states: CO, FL, IL, NC, PA, SC, and TX.

Key facts

Status
Terminated
Initiation date
2017-12-15
Report date
2018-04-04
Termination date
2019-07-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Reading, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1194-2018