LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25). Product Code: SET-0013-25.
Reported: August 6, 2025 Initiated: June 24, 2025 #Z-2232-2025
Product Description
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25). Product Code: SET-0013-25.
Reason for Recall
Potential for external cassette leaks
Details
- Recalling Firm
- Fresenius Kabi USA, LLC
- Units Affected
- 19,225 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.
- Location
- North Andover, MA
Frequently Asked Questions
What product was recalled? ▼
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25). Product Code: SET-0013-25.. Recalled by Fresenius Kabi USA, LLC. Units affected: 19,225 units.
Why was this product recalled? ▼
Potential for external cassette leaks
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 6, 2025. Severity: Moderate. Recall number: Z-2232-2025.
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