FDA Device recall Z-1158-2018
Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for use…
- FDA Device
- Class II
- terminated
- Published 2018-03-28
On 2018-03-28 the FDA classified a Class II recall of Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for use… by Arrow International, citing 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 b….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1158-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-11-14 |
| Published | 2018-03-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Arrow International |
| Distribution | US |
Product
Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters. Permits venous access and catheter introduction to the central circulation.
Reason
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.
Identifiers
| code_info | ASK-09903-ECL 23F16H0387 23F16H0595 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1158-2018%22
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