Z-2338-2017 Class II Terminated
FDA device recall Z-2338-2017 was initiated by Arrow International Inc on May 9, 2017 and is designated Class II. 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. The recall status is terminated (terminated September 17, 2018). Affected quantity: 27,485 units distributed in U.S., 4,371 units distributed internationally.
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