FDA Device recall Z-2619-2018
147" (373 cm) Bifuse Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿ w/Remv 3 Gang 1o2¿ Manifold (Blue, Yellow, Red), Check Valve Rotati…
- FDA Device
- Class II
- terminated
- Published 2018-08-15
On 2018-08-15 the FDA classified a Class II recall of 147" (373 cm) Bifuse Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿ w/Remv 3 Gang 1o2¿ Manifold (Blue, Yellow, Red), Check Valve Rotati… 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-2619-2018 |
| 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
147" (373 cm) Bifuse Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿ w/Remv 3 Gang 1o2¿ Manifold (Blue, Yellow, Red), Check Valve Rotating Luer, 1 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 B5216, Lot Number 3335222, 3356780, 3391845, 3401803, 3405384, 3412076, 3416485, 3416486, 3419516, 3429619, 3429620, 3432660 |
|---|
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-2619-2018%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.