LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Product Code: SET-0032-
FDA device recall Z-2235-2025 · posted 2025-08-01 · Open, Classified
Recall details
- Recalling firm
- Fresenius Kabi USA, LLC
- Reason for recall
- Potential for external cassette leaks
- Action taken
- 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
- Status
- Open, Classified
- Product code
- FRN
- Quantity affected
- 348,150 units
- Distribution
- 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.
- Date initiated
- 2025-06-24
- Date posted
- 2025-08-01
- Location
- North Andover, MA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Ivenix Infusion System (IIS) (K183311) | Ivenix, Inc. | 2019-06-07 |