FDA Early Alert: Large Volume Pump Primary Administration Set Reverse Flow Issue from Fresenius Kabi
Affected Product
The FDA is aware that Fresenius Kabi has issued a letter to affected customers recommending certain Ivenix large volume pump (LVP) Primary Administration sets be removed from where they are used or sold:
- LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site
- Product Code: SET-0032-01 (individual unit), SET-0032-25 (case)
- Lot: FA25B03126
- Unique Device Identifier: 00811505030214
What to Do
Check your inventory for affected stock and discontinue use and distribution immediately. On October 30, Fresenius Kabi sent all affected customers a letter recommending the following actions:
- Discontinue the use and distribution of the affected product immediately. Check your inventory and quarantine all affected product at your facility.
- Inform potential product users in your organization of this notification and replace with unaffected product.
- Complete the attached Customer Reply Form and return it via the fax number or email address listed in the reply form. If your facility further distributes or transfers products to satellite sites or other locations, please inform all downstream customers about this recall.
- Option A: If you no longer have any inventory of the affected product, please complete the response form and return it to Fresenius Kabi.
- Option B: If you have affected product in your inventory, please either destroy it or return it. If you have questions or need to request replacement inventory, contact Fresenius Kabi Customer Service at 855-354-6387 (Prompt 1). If you choose to destroy the product, Fresenius Kabi will provide a Certificate of Destruction, which must be completed and returned.
Check the FDA web page for updates. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.