Peripherally Inserted Midline Catheter Kit with Placement Wire — Class II medical device recall Z-2385-2018
Terminated recall by Arrow International Inc, reported 2018-07-18, distributed nationwide. Product pouch label may not easily identify the lot number, expiration date and associated symbols..
| Recall number | Z-2385-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Arrow International Inc, Reading, PA, United States |
| Recall initiated | 2018-05-17 |
| Classified | 2018-07-07 |
| Reported by FDA | 2018-07-18 |
| Terminated | 2020-12-02 |
| Distributed | Nationwide (US) |
| Quantity | 2,070 units |
| Reason classes | labeling |
| Lot numbers | 13F16M0102 |
| Model numbers | MK-02031-TW |
Product
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..
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2385-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.