Data Foundry

Medical device recalls 2018

ARROW ENDURANCE" Extended Dwell Peripheral Catheter System — Class II medical device recall Z-1194-2018

Terminated recall by Arrow International Inc, reported 2018-04-04, distributed in CO, FL, IL, NC, PA, SC, TX. Certain lots of peripheral catheter systems may be missing the safety latch, intended to minimize the risk of

Recall numberZ-1194-2018
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmArrow International Inc, Reading, PA, United States
Recall initiated2017-12-15
Classified2018-03-26
Reported by FDA2018-04-04
Terminated2019-07-18
DistributedCO, FL, IL, NC, PA, SC, TX
Quantity305
Lot numbers13F17F0120, 14X17C0039
Model numbersEDC-00820, EDC-00820-B
Expiration dates2019-02-20, 2019-05-20

Product

ARROW ENDURANCE" Extended Dwell Peripheral Catheter System, Catalog Numbers: EDC-00820 & EDC-00820-B

Reason for recall

Certain lots of peripheral catheter systems may be missing the safety latch, intended to minimize the risk of sharps injuries.

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-1194-2018. 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.