Baxter Recalls Multirate Infusor Devices Due to Rupture Complaints
Baxter Healthcare is recalling 3,255,096 Multirate Infusor Devices due to an increase in rupture complaints. The devices are indicated for the intravenous administration of medications.
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 score.
Plain-English summary
Baxter Healthcare Corporation is issuing an urgent product recall for Multirate Infusor Devices. These devices are indicated for the intravenous administration of medications. The recall affects 3,255,096 units distributed nationwide and in Puerto Rico.
The recall is being conducted due to an increase in rupture complaints. Baxter has implemented product and process improvements that have substantially improved product quality, and complaint rates for ruptures have since decreased. The company is ensuring that no affected product remains in the field.
The affected product codes are 2C1154KP, 2C1155KP, 2C9960KP, and 2C9961KP. The lot numbers are 10F030, 10F066, 10H043, 10H104, 10K027, 10K099, 10M090, 10G028, 10J059, 10M019, 10M089, 10F058, 10G069, 10G042, 10J048, and 10M026. The expiration date for these units is 06/30/13.
The recalled product
- Product
- Brand Name: Multirate Infusor Devices. Indicated for the intravenous administration of medications.
- Manufacturer
- Baxter Healthcare Corp.
- Category
- Medical Device — Infusion Pumps
- 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 (3)
- Product Codes: 2C1154KP
- 2C1155KP
- 2C9960KP
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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