FDAFDA · Food and drugs·Recall number Z-1601-2013
Brand Name: Multirate Infusor Devices. Indicated for the intravenous administration of medications.
Published July 3, 2013 · Recall initiated: June 7, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints. Baxter has implemented product and process improvements which have substantially improved product quality. Complaint rates for ruptures have since decreased. Baxter wants to ensure that no affected product remains in the field.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Baxter Healthcare Corp.
- Distributor
- Distributed Nationwide and in Puerto Rico.
- Lot
- Product Codes: 2C1154KP, 2C1155KP, 2C9960KP, 2C9961KP Lot Numbers: 10F030 10F066 10H043 10H104 10K027 10K099 10M090 10G028 10J059 10M019 10M089 10F058 10G069 10G042 10J048 10M026 Expiration Date: 06/30/13
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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