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

Recall Z-0993-2013 — Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.

U.S. FDA — Device Enforcement · United States · 2013-01-03 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0993-2013
Date of alert: 2013-01-03
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Animas Corporation
Product category: device
Product type: Devices

Reported risk: Animas has identified a component issue affecting a small supply of the Animas(R) 2020 insulin pumps. The component issue may trigger the pumps to sound a false alarm or warning related to one of the following: - Loss of prime; -Occlusion; or -No cartridge detected.

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-0993-2013 — Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.

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