Reported Feb 11, 2015 · Terminated
Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion of insulin for the…
Animas Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Animas Corporation · 200 Lawrence Dr · West Chester, PA · 19380-3428
Is this the product you have?
- Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion of insulin for the treatment of diabetes and has a continuous glucose monitoring feature.
- Lot codes and dates
- Model Number(s)
100515-63100510-63100514-63100512-63100511-63101200-03100201-03101202-03101204-03101205-03101200-53101202-53101205-53101200-02101200-57101201-57101202-57101204-57101205-57101200-63101201-63101202-63101204-63101205-63101206-63
- Model Number(s)
- Amount recalled
- 1235
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Animas Corporation recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.