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Use caution Medical device recall · FDA · Published December 15, 2017

Arrow Endurance Catheter System Recall: Missing Safety Latch Risk

Arrow recalls specific catheter systems with missing safety latches that could cause sharps injuries. Affected units have catalog numbers EDC-00820 or EDC-00820-B with listed lots. Contact Arrow for details.

🇺🇸 FDA recall #Z-1194-2018Medical deviceArrow ›
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Contact the company

Recalling firmArrow International Inc2400 Bernville Rd · Reading, PA 19605-9607
✎ GovInfoNow plain-language explainer

What happened, in plain English

Arrow is recalling certain catheter systems that may be missing the safety latch, which could lead to sharps injuries. This is a safety issue for medical users who might accidentally puncture themselves. Read more at govinfonow.com/recall/72319-arrow-endurance-catheter-system-recall-missing-safety-latch-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/72319-arrow-endurance-catheter-system-recall-missing-safety-latch-risk · Updated August 31, 2026 · FDA enforcement record: FDA #Z-1194-2018

Cite this page

“Arrow Endurance Catheter System Recall: Missing Safety Latch Risk.” GovInfoNow, updated August 31, 2026. https://govinfonow.com/recall/72319-arrow-endurance-catheter-system-recall-missing-safety-latch-risk. Based on FDA recall #Z-1194-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1194-2018%22&limit=1).

Why it’s dangerous

The safety latch is designed to prevent accidental punctures from the catheter's sharp tip. Without it, users could injure themselves during insertion or removal.

Who’s affected

Medical professionals and patients using the Arrow Endurance catheter system are most at risk. Those with the specific catalog numbers and lots listed are affected.

How to tell if you have this one

Check for catalog numbers EDC-00820 or EDC-00820-B. Lot numbers 14X17C0039 (expires Feb 2019) for EDC-00820 and 13F17F0120 (expires May 2019) for EDC-00820-B.

  • Brand
    Arrow
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check for Missing Latch

    Inspect the catheter system for the safety latch; if missing, stop using it immediately.

Where it went and when

Where it was distributed

Distributed in 7 states.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: yesILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: yesPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: yesCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: yesTXFlorida: yesFL

FDA distribution: “Distributed in the following U.S. states: CO, FL, IL, NC, PA, SC, and TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Colorado, Florida, Illinois, North Carolina, Pennsylvania, South Carolina, Texas.

Recall timeline

FDA terminated this recall 19 months after the firm started it.

1. Firm started the recall: Dec 15, 201712. FDA classified it Class II: Mar 26, 201823. Published in FDA’s Enforcement Report: Apr 4, 201834. FDA terminated the recall: Jul 18, 2019420172019
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. 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-1194-2018 (December 15, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1194-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on August 31, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA