Alaris PCA Module recall
Alaris PCA Module Model 8120, a modular infusion pump and monitoring system
Why was Alaris PCA Module recalled?
Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with a CHANNEL DISCONNECTED message, and an audio/visual alarm on the PC Unit and an interruption of therapy or monitoring.
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?
During cleaning, updated cleaning instructions and IUI covers must be used for all serial numbers.
- Product
- Alaris PCA Module Model 8120, a modular infusion pump and monitoring system
- Recalling firm
- CareFusion 303, Inc.
- Quantity
- 83532
- Distribution
- Worldwide distribution. US nationwide including Guam, Puerto Rico, American Samoa, and Military Pacific. Countries of: TR, QA, CA, AE, KW, MX, GI, IL, SA, CH, NL, BE, TW, ZA, PH, CN, AU, IN, FR, MY, NZ, GB, KR, PK, DE, SG, JP, CU, IT, and BH
- Recall date
- August 12, 2020
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)