Device product

Arrow Endurance" Extended Dwell Peripheral Catheter System, REF: ASK-00820-FLH

Z-0837-2020

December 06, 2019

Class II

Product summary

Firm: Arrow International Inc
Event: Event 84520
Status: Terminated
Classification: Class II
Quantity: 575
Official record key: device-enforcement:Z-0837-2020

Official wording

Reason: Potential sterility issue for specific lots of the Arrow Endurance" Extended Dwell Peripheral Catheter System, Product Code ASK-00820-FLH.

Code information: REF: ASK-00820-FLH Manufacturing Lots: 13F19E0247, 13F19F0006, and 13F19G0433 Exp. Date: Aug. 2020 - Sep. 2020

Distribution pattern: US: FL

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Potential sterility issue for specific lots of the Arrow Endurance" Extended Dwell Peripheral Catheter System, Product Code ASK-00820-FLH.