Pressure Injectable Multi- Lumen Central Venous Catheterization Kit… — Class II medical device recall Z-1161-2018
Terminated recall by Arrow International Inc, reported 2018-03-28, distributed nationwide. Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Ch
| Recall number | Z-1161-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Arrow International Inc, Reading, PA, United States |
| Recall initiated | 2017-11-14 |
| Classified | 2018-03-22 |
| Reported by FDA | 2018-03-28 |
| Terminated | 2019-07-15 |
| Distributed | Nationwide (US) |
| Quantity | 18,124 total |
Product
Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features, and Maximal Barrier Precautions. Permits venous access to central circulation.
Reason for recall
Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of best practices during central line insertions.
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-1161-2018. 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.