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Ivenix, Inc. recallZ-2721-2024 · Fresenius Kabi USA, LLC · initiated Aug 1, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Fresenius Kabi USA, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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).

FDA root cause category: Process control

What the company is doing

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: [email protected] 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)

Recall details

Recall number
Z-2721-2024
Status
Open, Classified
Initiated by the company
Aug 1, 2024
Posted by the FDA
Sep 4, 2024
Recalling firm
Fresenius Kabi USA, LLC
Quantity
180 cases/4,500 pieces
Product code
FPA
FDA submissions
K183311
Distribution
US Distribution to states of: CO, ID, NJ, UT.

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.

Code information (models, lots, serial numbers)

Product Code: SET-0013-25; UDI-DI: 00811505030054; Lot number: 3010538.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

4 devices cleared under K183311 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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