FDA Device recall Z-2716-2017
18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, NanoClave¿, Rotating Luer
- FDA Device
- Class II
- terminated
- Published 2017-07-19
On 2017-07-19 the FDA classified a Class II recall of 18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, NanoClave¿, Rotating Luer by Icu Medical, citing the connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2716-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-05-30 |
| Published | 2017-07-19 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Icu Medical |
| Distribution | AZ, OH, TX, WA |
Product
18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, NanoClave¿, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein).
Reason
The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.
Identifiers
| code_info | Lot No. 3172948, 3192947, 3224228, 3246765, 3260270. Item No. 011-AM6111 |
|---|
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-2716-2017%22
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