CADD Solis VIP Ambulatory Infusion Pump recall
CADD Solis VIP Ambulatory Infusion Pump, Model 21-21210, Reorder 21-2120-0102-15,
Why was CADD Solis VIP Ambulatory Infusion Pump recalled?
20 Pumps sold to the Finnish market contain a message in which one word in the message is mistranslated. When the user follows a specific set of key presses the pump will display the incorrect message. The message indicates that a Patient Controlled Analgesia (PCA) dose is unavailable because the pump is running. It should indicate that the PCA dose is not available because the pump is stopped. The function of the pump is unchanged and no patient injury can occur since no drug is being delivered.
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?
1071155, 1076826, 1081258, 1081260, 1081275, 1082475, 1082511, 1082512, 1090347, 1090348, 1090349, 1091767, 1091768, 1091769, 1091770, 1091771, 1092395, 1100186, 1100188, 1100189.
- Product
- CADD Solis VIP Ambulatory Infusion Pump, Model 21-21210, Reorder 21-2120-0102-15,
- Recalling firm
- Smiths Medical ASD, Inc.
- Quantity
- 20
- Distribution
- Internationally to Finland
- Recall date
- March 22, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)