LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. for intravenous infusion.
- Company
- Fresenius Kabi Usa, Llc
- Recall Initiated
- August 1, 2024
- Posted
- September 4, 2024
- Recall Number
- Z-2721-2024
- Quantity
- 180 cases/4,500 pieces
- Firm Location
- North Andover, MA
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).
Distribution
US Distribution to states of: CO, ID, NJ, UT.
Lot / Code Info
Product Code: SET-0013-25; UDI-DI: 00811505030054; Lot number: 3010538.
Root Cause
Process control
Action Taken
On August 1, 2024, consignees were notified by phone with a follow-up "URGENT - VOLUNATERY RECALL" letter sent August 2, 2024. Required Actions for Users: 1. Discontinue use and distribution of the affected product immediately. Check your inventory and quarantine all affected product at your facility. 2. Inform potential users of the product in your organization of this notification and replace with un-affected product. 3. Complete the attached Customer Reply Form, and return it via the fax number, or email address provided in the letter. Option A: if you have no remaining inventory of the affected product, please complete the response form, and return it to Fresenius Kabi. Option B: If you have affected product in inventory, please destroy or return the product and request replacement inventory. The enclosed Customer Reply Form acknowledges your receipt of this notification. If you have any questions, or require additional information, please contact Fresenius Kabi at 855-354-6387. 4. Please contact Fresenius Kabi Customer Service at 855-354-6387, Prompt 1, if you intend to destroy recalled product and/or request replacement product. If you intend to destroy recalled product, Fresenius Kabi will provide a certificate of destruction for completion. Once completed, the certificate should be returned to Fresenius Kabi. For Further Inquiries please contact Fresenius Kabi: Adverse Events/Quality Problems: Adverse reactions or quality problems experienced with the use of this product should be reported via the following: Ivenix_support@fresenius-kabi.com or 1/855-354-6387 (Normal Business Hours are Monday through Friday 8:30 AM to 5 PM Eastern Time, After Hours Supported with Voicemail Messaging)