Data Foundry

Medical device recalls 2017

Vascular catheter introduction kit The PICC is indicated for short or… — Class II medical device recall Z-1228-2017

Terminated recall by Arrow International Inc, reported 2017-03-01, distributed nationwide. There have been complaints for peel away sheaths flaring

Recall numberZ-1228-2017
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmArrow International Inc, Reading, PA, United States
Recall initiated2017-01-11
Classified2017-02-22
Reported by FDA2017-03-01
Terminated2018-09-06
DistributedNationwide (US)
Quantity215,703 units

Product

Vascular catheter introduction kit The PICC is indicated for short or long term peripheral access to the central Venous system for intravenous therapy, blood sampling, infusion and power injection of contrast media.

Reason for recall

There have been complaints for peel away sheaths flaring

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-1228-2017. 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.