Animas Vibe Insulin Infusion Pump. This product is recall
Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion of insulin for the treatment of diabetes and has a…
Why was Animas Vibe Insulin Infusion Pump. This product is recalled?
Calibration factors in the pump overwritten during a programming step. The force sensor could send a lower signal value to the pump processor, with loss of prime warnings, occlusion alarms and the pump unable to detect a cartridge during the prime sequence. Field action initiated 8/29/2011.
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?
Model Number(s): 100515-63 100510-63 100514-63 100512-63 100511-63 101200-03 100201-03 101202-03 101204-03 101205-03 101200-53 101202-53 101205-53 101200-02 101200-57 101201-57 101202-57 101204-57 101205-57 101200-63 101201-63 101202-63 101204-63 101205-63 101206-63
- Product
- Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion of insulin for the treatment of diabetes and has a…
- Recalling firm
- Animas Corporation
- Quantity
- 1235
- Distribution
- No US distribution, Distributors are located in France, Germany, Sweden and United Kingdom.
- Recall date
- February 11, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)