This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.
Reason for Recall
Fresenius Kabi is recalling a certain lot of the Ivenix LVP Primary Administration Sets after identifying a manufacturing defect that may cause uncontrolled medication flow.
The use of affected product may cause serious adverse health consequences, including medication overdose and death. There have been two reported injuries. There have been no reports of death.
Affected Product
- Product Names: Ivenix LVP Primary Administration Sets Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25)
- Unique Device Identifier (UDI)/Product Code: 20811505030058/SET-0013-25
- Lot: 3010538
What to Do
- Do not use affected product. This recall is limited to a specific lot: 3010538. Other lots are not affected.
On August 2, 2024, Fresenius Kabi sent all affected customers an Urgent Voluntary Recall letter recommending the following actions:
- Stop using and distributing affected product immediately.
- Check inventory and quarantine affected product.
- Destroy or return affected product and request replacements.
- Contact Fresenius Kabi Customer Service at 855-354-6387, Prompt 1, if you intend to destroy recalled product or request replacements.
- Replace inventory with unaffected product.
- Make sure all potential users are aware of the notification.
- Complete the customer reply form included with the letter by fax or email, even if there is no affected product on hand.