ArrowADVANTAGE5" Pressure Injectable Peripherally Inserted Central… — Class II medical device recall Z-0182-2018
Terminated recall by Arrow International Inc, reported 2017-12-06, distributed nationwide. There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required
| Recall number | Z-0182-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Arrow International Inc, Reading, PA, United States |
| Recall initiated | 2017-06-01 |
| Classified | 2017-11-28 |
| Reported by FDA | 2017-12-06 |
| Terminated | 2020-04-13 |
| Distributed | Nationwide (US) |
| Lot numbers | 23F16L0021 |
Product
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
Reason for 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.
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-0182-2018. 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.