FDA Device recall Z-1996-2014
Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usage: Catheter extension set for high pressure procedures
- FDA Device
- Class II
- terminated
- Published 2014-07-16
On 2014-07-16 the FDA classified a Class II recall of Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usage: Catheter extension set for high pressure procedures by Rgi Medical Manufacturing, citing problem with low adhesion of the tubing to luer connection which may lead to a separation of the extension set while in use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1996-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-03-28 |
| Published | 2014-07-16 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Rgi Medical Manufacturing |
| Distribution | US |
Product
Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usage: Catheter extension set for high pressure procedures.
Reason
Problem with low adhesion of the tubing to luer connection which may lead to a separation of the extension set while in use.
Identifiers
| code_info | Lot numbers 102131 and 110531. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1996-2014%22
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