Arrow PICC Kit Recalled: May Contain Wrong Sheath Size
Arrow International recalls PICC kits that might have 5Fr instead of 4Fr peel-away sheaths. This could cause complications during medical procedures. Affected kits have specific lot numbers.
Lower-risk recall
There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths.
Contact the company
What happened, in plain English
Arrow International is recalling PICC kits that may contain 5Fr peel-away sheaths instead of the required 4Fr size. This mismatch could lead to complications during medical procedures if used improperly. Read more at govinfonow.com/recall/73979-arrow-picc-kit-recalled-may-contain-wrong-sheath-size.
Source Summary by GovInfoNow · govinfonow.com/recall/73979-arrow-picc-kit-recalled-may-contain-wrong-sheath-size · Updated September 23, 2026 · FDA enforcement record: FDA #Z-0180-2018
Cite this page
“Arrow PICC Kit Recalled: May Contain Wrong Sheath Size.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/73979-arrow-picc-kit-recalled-may-contain-wrong-sheath-size. Based on FDA recall #Z-0180-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0180-2018%22&limit=1).
Why it’s dangerous
The kits might include 5Fr peel-away sheaths instead of the required 4Fr size. This mismatch could cause improper insertion or complications during medical procedures if the sheath is too large for the patient's vein.
Who’s affected
Healthcare professionals using the Arrow PICC kits for intravenous therapy are most at risk. Patients receiving care with these kits could face complications if the sheath size is incorrect.
How to tell if you have this one
Check the lot number on the kit packaging. The affected kits have lot number 23F16M0263. The product is used for intravenous therapy and central venous access.
- 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
Nationwide Distribution to AZ, CA, MA, MO, NC, NY, OR & SD
| Recall number | Product, codes & lots |
|---|---|
| Z-0179-2018 | Arrow(R) VPS(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter The intended use of the VPS Stylet and Console (VPS System) is to quickly and accurately guide market available peripherally inserted central catheters (PICCs) to the goal location which is to the cavo-atrial junction near the sino-atrial node; Lot/Batch Numbers: 23F16M0017 |
| Z-0180-2018 | ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, power injection of contrast media and allows for central venous pressure monitoring; Lot/Batch Number: 23F16M0263 |
| Z-0181-2018 | ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, power injection of contrast media and allows for central venous pressure monitoring; Lot/Batch Number: 23F16K0055 |
| Z-0182-2018 | ArrowADVANTAGE5" Pressure Injectable Peripherally Inserted Central Catheter (PICC) The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, power injection of contrast media and allows for central venous pressure monitoring; Lot/Batch Number: 23F16L0021 |
What to do — step by step
Check Kit Lot Number
Look for lot number 23F16M0263 on the packaging to identify affected kits.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 8 states.
FDA distribution: “Nationwide Distribution to AZ, CA, MA, MO, NC, NY, OR & SD” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Massachusetts, Missouri, New York, North Carolina, Oregon, South Dakota.
Recall timeline
FDA terminated this recall 2.9 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.
Questions people ask
Is there a risk of serious injury?
The recall indicates a potential for complications during medical procedures, but the risk is not described as causing serious injury in normal use.
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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-0180-2018 (June 1, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0180-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 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.