FDAFDA · Food and drugs·Recall number Z-1603-2013
Brand Name: Intermate Infusion Pump. 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: 2C1064K Lot Codes: 10F007 10F077 10H075 10J097 10K076 10K112 10M062 Expiration Date: 06/30/13
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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