The Recall Desk
ModerateFDA (Devices)·Z-0005-2013·Announced 2012-10-10

Animas Insulin Pumps Recalled for Keypad Wear and Peeling

Animas Corporation is recalling insulin pumps due to keypad wear that may cause tearing or peeling. The recall covers 236,470 units distributed worldwide.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a physical defect (keypad wear) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Animas Corporation is recalling specific models of insulin infusion pumps, including the IR1200, IR1250 (IR1200 Plus), 2020, and One Touch Ping glucose management systems. The recall involves 236,470 units that were distributed nationwide in the United States and in various countries including Canada, the United Kingdom, and several European and Asian nations.

The recall is being issued because of wear on the device keypad, which may lead to damage such as tearing or peeling of the keypad edge from the pump. This physical defect affects the integrity of the user interface on the insulin delivery device.

Consumers who possess these specific part numbers should contact Animas Corporation for further instructions on how to proceed with the recall. The affected part numbers are listed in the official recall documentation.

The recalled product

Product
IR1200, IR1250(IR1200 Plus), 2020 and One Touch(R) Ping(R) Insulin Pump glucose management system. The device is intended to deliver insulin therapy.
Manufacturer
Animas Corporation
Category
Medical Device — Insulin Pump
Hazard
Affected units
236,470

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • OneTouch(R) Ping(TM) Glucose Management Systems - Part Numbers 101420-00
  • 101421-00
  • 101422-00
  • 101424-00
  • 101425-00
  • 100430-00
  • 100431-00
  • 100432-00
  • 100434-00
  • 100435-00
  • 101420-98
  • 101421-98
  • 101422-98
  • 101424-98
  • and 101425-98
  • Animas(R) 2020 Insulin Infusion Pumps - Part numbers 101370-00
  • 101371-00
  • 101372-00
  • 101374-00
  • 101375-00

Distribution

Distributed nationwide across the United States.

The notice also names 50 states specifically:

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