Baxter SIGMA Spectrum Infusion Pump with Master Drug recall: Software Issue
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administration of…
Why was Baxter SIGMA Spectrum Infusion Pump with Master Drug recalled?
There is a potential software error during programming.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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 Code 35700BAX, GTIN 00085412091587
- Product
- Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administration of…
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 293,926 devices
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Canada, Barbados, Jamaica, Bermuda, Guyana, Bahamas, and Trinidad and Tobago.
- Recall date
- December 30, 2020
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)