FDA Device recall Z-2233-2025
LVP Blood Products Administration Set Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter (Qty 20)
- FDA Device
- Class II
- ongoing
- Published 2025-08-06
On 2025-08-06 the FDA classified a Class II recall of LVP Blood Products Administration Set Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter (Qty 20) by Fresenius Kabi Usa, citing potential for external cassette leaks.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2233-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-06-24 |
| Published | 2025-08-06 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Fresenius Kabi Usa |
| Distribution | US |
Product
LVP Blood Products Administration Set Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter (Qty 20). Product Code: SET-0014-20.
Reason
Potential for external cassette leaks
Identifiers
| code_info | Product Code: SET-0014-20. UDI-DI: 00811505030030. Lot Codes: FA24K05023, FA24L02010, FA24L04198, FA24L04214. |
|---|
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-2233-2025%22
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