Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion of insulin for the treatment of diab...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0136-2015.
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.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0136-2015.
Recall terminated by FDA.
🩺 Talk to your doctor or pharmacist
Product Recall Tracker does not provide medical advice. Any specific instructions about this medication or device come directly from the FDA notice above. Before making any change to your treatment:
- Do not stop, change, or discard your prescription on your own.
- Call your doctor or pharmacist and ask whether this FDA notice applies to your prescription (have the brand name, dosage, and lot number ready if you can find them).
- Follow your clinician's guidance on whether to continue, switch, or return the product.
- If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
- For the official FDA notice, visit the FDA recalls page.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0136-2015.
Animas Corporation
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If you had an adverse reaction, side effect, or device malfunction from this medication or device, report it to the FDA through MedWatch. Talk to your doctor or pharmacist first — do not stop a prescription on your own. Reports help the FDA detect rare or emerging safety signals and can lead to label changes or recalls.
Animas Corporation Recall FAQ
Animas Corporation is the subject of a diabetes devices safety report: Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion of insulin for the treatment of diab.... The notice was published on June 10, 2014 by the U.S. Food and Drug Administration (FDA). Approximately 1,028 units are potentially affected.