Recall Z-2721-2024— Fresenius Kabi USA, LLC
Class I · Ongoing
Class I FDA medical device recall by Fresenius Kabi USA, LLC, initiated 2024-08-01. It names one FDA 510(k) clearance: K183311. Product: LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. for intravenous infusion.. Reason: A defect may cause an uncontrolled medication flow condition which may result in a dose greater than prescribed for the patient (i.e., medication overdose)..
- Recalling firm
- Fresenius Kabi USA, LLC
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2024-08-01
- Firm location
- North Andover, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. for intravenous infusion.
Reason for recall
A defect may cause an uncontrolled medication flow condition which may result in a dose greater than prescribed for the patient (i.e., medication overdose).
Data sourced from openFDA. This site is unofficial and independent of the FDA.