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Open, Classified

LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25). Product Code: SET-0013-25.

FDA Recall Z-2232-2025 · Posted 2025-08-01

Recalling FirmFresenius Kabi USA, LLC
Recall StatusOpen, Classified
Product CodeFRN
Date Initiated2025-06-24
Product Quantity19,225 units

Reason for Recall

Potential for external cassette leaks

Firm Action

Fresenius Kabi notified consignees on about 06/24/2025 via telephone call and followed up with a letter. Consignees were instructed to discontinue use and distribution immediately, quarantine any affected units on hand, notify users of the issue, and complete and return the Customer Reply Form. If affected units were further distributed, consignees were instructed to notify those customers. If Affected units were on hand, consignees were instructed to either destroy or arrange for their return. Replacement of affected units can be arranged.

Root Cause

Process design

Distribution Pattern

US Nationwide distribution in the states of CA, CO, DE, FL, GA, ID, IL, MA, MD, MI, MN, MS, NJ, NV, OK, OR, SC, TX, VA, WA, WI.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K183311Ivenix Infusion System (IIS)Ivenix, Inc. · 2019-06-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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