Brand Name: Regional Analgesia Infusor System with recall
Brand Name: Regional Analgesia Infusor System with Patient Control. Indicated for the intravenous administration of medications.
Why was Brand Name: Regional Analgesia Infusor System with recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Product Codes: 2C1154KP, 2C1155KP, 2C9960KP, 2C9961KP Lot Numbers: 10F030 10F066 10H043 10H104 10K027 10K099 10M090 10G028 10J059 10M019 10M089 10F058 10G069 10G042 10J048 10M026 Expiration Date: 06/30/13
- Product
- Brand Name: Regional Analgesia Infusor System with Patient Control. Indicated for the intravenous administration of medications.
- Recalling firm
- Baxter Healthcare Corp.
- Quantity
- 3,255,096 total
- Distribution
- Distributed Nationwide and in Puerto Rico.
- Recall date
- July 3, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)