Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0137-2015 — Animas Vibe Insulin Infusion Pump and System. These products are indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.

U.S. FDA — Device Enforcement · United States · 2012-10-25 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0137-2015
Date of alert: 2012-10-25
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Animas Corporation
Product category: device
Product type: Devices

Reported risk: Animas determined that keypad wear over time was contributing to an increased complaint rate associated with damaged keypads on the Vibe Insulin Infusion Pump and System. Animas has implemented an improvement to the keypad related to the material used to reduce susceptibility to damage and increase durability.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-0137-2015 — Animas Vibe Insulin Infusion Pump and System. These products are indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.

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