FDA Device recall Z-2649-2018
159" (404 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 4-Way Stopcock, 3 Pre-Pierced Ports, Luer Lock, 2 Ext, Sterile The bloo…
- FDA Device
- Class II
- terminated
- Published 2018-08-15
On 2018-08-15 the FDA classified a Class II recall of 159" (404 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 4-Way Stopcock, 3 Pre-Pierced Ports, Luer Lock, 2 Ext, Sterile The bloo… by Icu Medical, citing some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2649-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-07-31 |
| Published | 2018-08-15 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Icu Medical |
| Distribution | US |
Product
159" (404 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 4-Way Stopcock, 3 Pre-Pierced Ports, Luer Lock, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.
Reason
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
Identifiers
| code_info | Item Number Z2902, Lot Number 69-365-SJ, 69-707-SJ, 70-196-SL, 70-400-SL, 70-759-SL, 70-918-SL, 70-952-SJ, 71-189-Y1, 7…Item Number Z2902, Lot Number 69-365-SJ, 69-707-SJ, 70-196-SL, 70-400-SL, 70-759-SL, 70-918-SL, 70-952-SJ, 71-189-Y1, 71-562-Y1, 71-669-Y1, 71-861-Y1, 73-604-HE, 73-877-HE, 74-014-JW, 74-320-JW, 74-463-JW, 74-733-JW, 75-262-JW, 75-420-JW, 75-644-JW, 75-846-JW, 76-096-SJ |
|---|
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-2649-2018%22
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