FDA Device recall Z-2613-2018
Lopez Valve¿ w/Red Cap, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for…
- FDA Device
- Class II
- terminated
- Published 2018-08-15
On 2018-08-15 the FDA classified a Class II recall of Lopez Valve¿ w/Red Cap, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for… 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-2613-2018 |
| 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
Lopez Valve¿ w/Red Cap, 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 081-M9000R, Lot Number 3333003, 3352935, 3365932, 3383035, 3402533, 3413038 |
|---|
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-2613-2018%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.