Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion of insulin for the tre
FDA device recall Z-0136-2015 · posted 2014-10-24 · Terminated
Recall details
- Recalling firm
- Animas Corporation
- Reason for recall
- Animas determined that the Hebrew language translation in the Vibe Insulin Infusion Pump was incorrect and could lead to potential patient confusion. In addition, one line of Hebrew text was omitted from the display screen.
- Action taken
- A recall notification letter, dated June 2014, was sent to the recalling firm's sole customer, TriTech Biomed, in Israel, to notify them about the product, problem, and action to be taken. The distributor sent letters to their customers on July 16, 2014.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- N/A
- Quantity affected
- 1028
- Distribution
- International Distribution in Israel only.
- Date initiated
- 2014-06-10
- Date posted
- 2014-10-24
- Date terminated
- 2015-09-02
- Location
- West Chester, PA
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