Z-1365-2019 Class II Terminated
FDA device recall Z-1365-2019 was initiated by Arrow International Inc on Dec 13, 2018 and is designated Class II. Reason for recall: Kits labeled as containing a 40 cm PICC may contain a 50 cm PICC, and kits labeled as containing a 50 cm PICC may contain a 40 cm PICC The recall status is terminated (terminated Oct 1, 2020). Affected quantity: 963 units (US) in total.
Recall Details
- Product Type
- Devices
- Report Date
- May 22, 2019
- Initiation Date
- Dec 13, 2018
- Termination Date
- Oct 1, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 963 units (US) in total
Product Description
Arrow PICC powered by Arrow VPS Precision Stylet Product Code:CDC-45052-VPS2 Product Usage: The Arrow Pressure Injectable PICC is indicated for short-term or longterm peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media and allows for central venous pressure monitoring. The maximum pressure of pressure injector equipment used with the pressure injectable PICC may not exceed 300 psi.
Reason for Recall
Kits labeled as containing a 40 cm PICC may contain a 50 cm PICC, and kits labeled as containing a 50 cm PICC may contain a 40 cm PICC
Distribution Pattern
US Nationwide Distribution
Code Information
Lot /Batch Number: 23F18F0005, 23F18B0583 GTN:40801902120753
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1365-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026