FDA Device recall Z-0805-2018
STAT 2¿ I.V. Gravity Flow Needle-Free Controller Primary Administration Sets and Extension Sets (Catalog Numbers: (1) S2-12 N, STAT 2¿ Exte…
- FDA Device
- Class II
- terminated
- Published 2018-03-07
On 2018-03-07 the FDA classified a Class II recall of STAT 2¿ I.V. Gravity Flow Needle-Free Controller Primary Administration Sets and Extension Sets (Catalog Numbers: (1) S2-12 N, STAT 2¿ Exte… by Conmed, citing intravascular (I.V.) fluid administration sets are exhibiting inaccurate or inconsistent flow rates.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0805-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-06-19 |
| Published | 2018-03-07 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Conmed |
| Distribution | US |
Product
STAT 2¿ I.V. Gravity Flow Needle-Free Controller Primary Administration Sets and Extension Sets (Catalog Numbers: (1) S2-12 N, STAT 2¿ Extension Set Gravity Flow Controller (Needle-Free), 12 length, (2) S2V-20 N, STAT 2¿ Primary Administration Set Gravity Flow Controller (Needle-Free), 20 Drops/ml, 84 length, and (3) S2V-60 N, STAT 2¿ Primary Administration Set Gravity Flow Controller (Needle-Free), 60 Drops/ml, 84 length) The STAT 2¿ Extension sets are for use in conjunction with commonly available I.V. administration sets for controlling the infusion of I.V. fluids into the human body. The STAT 2¿ Secondary and Primary Administration Sets are for use in attachment to an I.V. bag and patient catheter inserted into a vein to control the infusion of intravenous fluids into the human body. This is a disposable device with a sterile, nonpyrogenic fluid path.
Reason
Intravascular (I.V.) fluid administration sets are exhibiting inaccurate or inconsistent flow rates.
Identifiers
| code_info | Catalog Number, Manufacturing Date range, Lot Code range: (1) S2-12 N,4/27/12 - 4/12/17, 120427X - 201704124; (2) S2V-2…Catalog Number, Manufacturing Date range, Lot Code range: (1) S2-12 N,4/27/12 - 4/12/17, 120427X - 201704124; (2) S2V-20 N, 4/27/12 - 11/7/17, 120427X - 201611074; and (3) S2V-60 N, 4/27/12 - 2/13/17, 120427X - 201702134 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0805-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.