Baxter Recalls Intermate Infusion Pumps Due to Rupture Complaints
Baxter Healthcare is recalling Intermate Infusion Pumps due to an increase in rupture complaints. The recall covers 3,255,096 units distributed nationwide and in Puerto Rico.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a structural defect (rupture) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity rating.
Plain-English summary
Baxter Healthcare Corporation is issuing an urgent product recall for Intermate Infusion Pumps. These devices are indicated for the intravenous administration of medications. The recall is being conducted due to an increase in complaints regarding product rupture.
The recall affects 3,255,096 units of the Intermate Infusion Pump. The specific product code is 2C1064K, and the affected lot codes are 10F007, 10F077, 10H075, 10J097, 10K076, 10K112, and 10M062. The expiration date for these units is 06/30/13. The products were distributed nationwide and in Puerto Rico.
Baxter has implemented product and process improvements that have substantially improved product quality, and complaint rates for ruptures have decreased since these changes. The company is conducting this recall to ensure that no affected product remains in the field.
The recalled product
- Product
- Brand Name: Intermate Infusion Pump. Indicated for the intravenous administration of medications.
- Manufacturer
- Baxter Healthcare Corp.
- Category
- Medical Device — Infusion Pump
- Hazard
- Affected units
- 3,255,096
Distribution
Part of a larger recall action
This product is one of 7 recalled by Baxter Healthcare Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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