IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25).
FDA device recall Z-0586-2026 · posted 2025-12-03 · Open, Classified
Recall details
- Recalling firm
- Fresenius Kabi USA, LLC
- Reason for recall
- Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
- Action taken
- An URGENT - Voluntary Recall notice dated 10/30/25 was emailed to consignees. Consignees are instructed to discontinue use and distribution of affected devices immediately; check inventory and quarantine all affected devices. The recall notification is to be shared with users and inventory replaced with unaffected stock. Consignees with no affected devices are to complete and return the provided response form. Consignees with affected devices are to either destroy or return affected devices; replacements can be requested by contacting Fresenius Kabi Customer Service at 855-354-6387 (x1). If consignees destroy product, Fresenius Kabi will provide a Certificate of Destruction which must be completed and returned. Consignees with any questions are to email Ivenix_support@fresenius-kabi.com or call 855-354-6387.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- FRN
- Quantity affected
- 483 cases (12,075 eaches)
- Distribution
- US Nationwide distribution in the states of IL, MD, MI, OK, SC, TX, VA & WI.
- Date initiated
- 2025-11-03
- Date posted
- 2025-12-03
- Location
- North Andover, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Ivenix Infusion System (IIS) (K183311) | Ivenix, Inc. | 2019-06-07 |