Z-2385-2018 Class II Terminated
FDA device recall Z-2385-2018 was initiated by Arrow International Inc on May 17, 2018 and is designated Class II. Reason for recall: Product pouch label may not easily identify the lot number, expiration date and associated symbols.. The recall status is terminated (terminated Dec 2, 2020). Affected quantity: 2070 units in total.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 18, 2018
- Initiation Date
- May 17, 2018
- Termination Date
- Dec 2, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2070 units in total
Product Description
Peripherally Inserted Midline Catheter Kit with Placement Wire, REF MK-02031-TW Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via the Superior Vena Cava (SVC). The VPS Rhythm Device is appropriate for final catheter tip placement in any catheter that is intended to be placed in the lower 1/3 of the SVC near the cavo-atrial junction (CAJ). Catheters that are traditionally considered CVCs that are intended to be placed in the right atrium, or any location other than the lower 1/3 SVC (e.g. chronic hemodialysis catheters placed in the right atrium).
Reason for Recall
Product pouch label may not easily identify the lot number, expiration date and associated symbols..
Distribution Pattern
US Nationwide Distribution in the states of AR, AZ, CT, FL, GA, IL, IN, KS, KY, MA, MI, MN, MO, NC, NJ, NY, OH, PA, SC, TX, VA & WA
Code Information
Lot Number: 13F16M0102
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2385-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026