BD Alaris Infusion Pump Module recall
BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad; and Pump Module Door Assembly Replacement Kit with Pump Module Keypad, Parts: 49000239…
Why was BD Alaris Infusion Pump Module recalled?
Pump Module keypad lifting, and Fluid ingress could result in 1) Unresponsive keys: module continues infusion, PC unit will not alarm and must be used for programming changes, may necessitate a different Pump Module. May result in infusion start delay/inability to titrate medication. 2) Stuck keys: PC unit alarms, module exhibits Channel Error, may result in infusion interruption/start delay
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?
Pump Module with Keypad: manufactured January 23, 2019 to December 5, 2019. Pump Module Door Assembly Kit with Keypad: Dated from January 15, 2019 to November 14, 2019.
- Product
- BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad; and Pump Module Door Assembly Replacement Kit with Pump Module Keypad, Parts: 49000239…
- Recalling firm
- CareFusion 303, Inc.
- Quantity
- 160300
- Distribution
- Worldwide distribution. US nationwide and countries of: AE, IL, IN, SA, BE, QA, SG, TW, KW, ZA, PH, AU, HU, NZ
- Recall date
- April 7, 2021
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)