Baxter Recalls Regional Analgesia Infusor Systems Due to Rupture Complaints
Baxter Healthcare is recalling Regional Analgesia Infusor Systems with Patient Control 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 is classified as FDA Class II and involves a risk-of-harm product (rupture of an infusion device) where specific injury reports are not detailed in the source text, fitting the criteria for a High severity score.
Plain-English summary
Baxter Healthcare Corporation is issuing an urgent product recall for the Regional Analgesia Infusor System with Patient Control. This medical device is indicated for the intravenous administration of medications. The recall is being conducted due to an increase in complaints regarding product ruptures.
The recall affects 3,255,096 units of the product. These units were distributed nationwide and in Puerto Rico. Specific product codes include 2C1154KP, 2C1155KP, 2C9960KP, and 2C9961KP, with various lot numbers and an expiration date of 06/30/13.
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: Regional Analgesia Infusor System with Patient Control. 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 (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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