Device product

ARROW ENDURANCE" Extended Dwell Peripheral Catheter System, Catalog Numbers: EDC-00820 & EDC-00820-B

Z-1194-2018

December 15, 2017

Class II

Product summary

Firm: Arrow International Inc
Event: Event 79474
Status: Terminated
Classification: Class II
Quantity: 305
Official record key: device-enforcement:Z-1194-2018

Official wording

Reason: Certain lots of peripheral catheter systems may be missing the safety latch, intended to minimize the risk of sharps injuries.

Code information: Catalog Number: EDC-00820, Lot: 14X17C0039 (Expires February 2019); Catalog Number: EDC-00820-B, Lot: 13F17F0120 (Expires May 2019)

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

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Certain lots of peripheral catheter systems may be missing the safety latch, intended to minimize the risk of sharps injuries.