Baxter Recalls Intermate Infusion Pumps Due to Rupture Complaints
Baxter Healthcare is recalling Intermate Infusion Pumps due to an increase in rupture complaints. The company states that product and process improvements have since reduced the complaint rate.
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 to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
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.
Baxter has implemented product and process improvements that have substantially improved product quality, and complaint rates for ruptures have decreased since these changes were made. The company is ensuring that no affected product remains in the field.
The recall involves 3,255,096 units distributed nationwide and in Puerto Rico. Affected product codes include 2C1730K, 2C1732K, 2C1734K, 2C1740K, 2C1743K, and 2C1744K. The expiration date for the affected lots is 06/30/13.
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
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Product Codes: 2C1730K
- 2C1732K
- 2C1734K
- 2C1740K
- 2C1743K
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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