Z-2338-2017 Class II Terminated

Recalled by Arrow International Inc — Reading, PA

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

Arrow Pressure Injectable PICC Kit Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days The Arrow Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling.

Reason for Recall

The Arrow Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling.

Distribution Pattern

Worldwide Distribution - US (nationwide) and Canada

Code Information

Material number: EU-04041-HPMSB, EU-05052-HPMSB, EU-05041-HPMSB Device Listing D000801