FDA Device recall Z-1869-2025
IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL. Intravascular Administra…
- FDA Device
- Class I
- ongoing
- Published 2025-06-18
On 2025-06-18 the FDA classified a Class I recall of IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL. Intravascular Administra… by Fresenius Kabi Usa, citing mis-assembly error of Blood Products Administrations Sets where the 200-micron drip chamber filter may be incorrectly positioned and unable to filter out large blood particulates.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1869-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-05-12 |
| Published | 2025-06-18 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Fresenius Kabi Usa |
| Distribution | CA, CO, DE, GA, IL, MD, MI, MN, MS, NC, NJ, NV, OK, SC, TX, VA, WA, WI |
Product
IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL. Intravascular Administration Set.
Reason
Mis-assembly error of Blood Products Administrations Sets where the 200-micron drip chamber filter may be incorrectly positioned and unable to filter out large blood particulates.
Identifiers
| code_info | Model No. SET-0014-20; UDI 20811505030034; Lot No. FA24K05015. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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FDA Drug · Class I · 2026-08-26 · Fresenius Kabi Usa - Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 25 Multiple-Dose Vials, 20 mL, Rx only, Sterile, Fresenius K…
FDA Drug · Class II · 2026-07-29 · Fresenius Kabi Usa - Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL (10 mg per mL), 25 Multiple-Dose Vials, 50 mL, Rx only, Sterile, Fresenius K…
FDA Drug · Class II · 2026-07-29 · Fresenius Kabi Usa - Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 mL fill in a 6.5 mL vial, Rx only, Multiple Dose Vials, Fresenius Kabi…
FDA Drug · Class II · 2026-07-29 · Fresenius Kabi Usa
All Fresenius Kabi Usa recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1869-2025%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.