Arrow Peripherally Inserted Midline Catheter Kit Recall: Pouch Label Missing Lot Number
Arrow recalls Peripherally Inserted Midline Catheter Kit with Placement Wire (REF MK-02031-TW) due to pouch label not clearly showing lot number, expiration date, or symbols. This may cause confusion during catheter use.
Lower-risk recall
Product pouch label may not easily identify the lot number, expiration date and associated symbols..
Contact the company
What happened, in plain English
Arrow is recalling a Peripher: Inserted Midline Catheter Kit with Placement Wire (REF MK-02031-TW) because the product pouch label may not clearly show the lot number, expiration date, or symbols. This could lead to confusion when using the catheter. Read more at govinfonow.com/recall/71035-arrow-peripherally-inserted-midline-catheter-kit-recall-pouch-label-missing.
Source Summary by GovInfoNow · govinfonow.com/recall/71035-arrow-peripherally-inserted-midline-catheter-kit-recall-pouch-label-missing · Updated August 21, 2026 · FDA enforcement record: FDA #Z-2385-2018
Cite this page
“Arrow Peripherally Inserted Midline Catheter Kit Recall: Pouch Label Missing Lot Number.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/71035-arrow-peripherally-inserted-midline-catheter-kit-recall-pouch-label-missing. Based on FDA recall #Z-2385-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2385-2018%22&limit=1).
Why it’s dangerous
The pouch label may not clearly show the lot number, expiration date, or symbols. This could cause confusion when verifying the catheter's details during medical procedures, but does not pose a direct safety risk.
Who’s affected
Healthcare professionals who use this catheter kit for real-time tip location monitoring may be affected. Patients receiving this catheter treatment are at low risk if the label issue is corrected.
How to tell if you have this one
Check for the product reference number MK-02031-TW on the pouch. The lot number is 13F16M0102, but the label may not clearly display this information.
- Brand
Arrow- Category
Medical device
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
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
| Recall number | Product, codes & lots |
|---|---|
| Z-2382-2018 | VPS Rhythm ECG Accessory Pack with Johans Adapter, REF RHY-100-ECGJ 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).; Lot Numbers: 13F17A0287 & 13F17C0018 |
| Z-2383-2018 | VPS Rhythm ECG Accessory Pack, REF RHY-100-ECGO 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).; Lot Number: 13F17A0288 |
| Z-2384-2018 | VPS TipTracker Stylet Accessory, REF RHY-177-TTSAP 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).; Lot Number: 13F17G0074 |
| Z-2385-2018 | 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).; Lot Number: 13F16M0102 |
What to do — step by step
Check Pouch Label
Look for the lot number, expiration date, and symbols on the pouch label to confirm the product details.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 22 states.
FDA distribution: “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” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, Arkansas, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Michigan, Minnesota, Missouri, New Jersey, New York, North Carolina, Ohio, Pennsylvania, South Carolina, Texas, Virginia, Washington.
Recall timeline
FDA terminated this recall 2.5 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2385-2018 (May 17, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2385-2018 to see it in context.
- Plain-language summary written by qwen3:4b on August 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.