Agency classClass IOur severity:Severe FDA (Devices)·Z-0993-2013·Announced 2013-04-10

Animas 2020 Insulin Pump Recall for False Alarm Component Issue

Animas Corporation is recalling 7,157 Animas 2020 insulin pumps due to a component issue that may cause false alarms for loss of prime, occlusion, or no cartridge detected.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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…"

Plain-English summary

Animas Corporation is recalling the Animas(R) 2020 Insulin Infusion Pump. The recall involves 7,157 units, including 494 pumps in the United States. The product is indicated for the continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.

The recall was initiated because Animas identified a component issue affecting a small supply of the pumps. This issue may trigger the devices to sound false alarms or warnings related to loss of prime, occlusion, or no cartridge detected.

The affected pumps were distributed worldwide, including nationwide in the United States and in several other countries. Consumers should check their pump's serial number against the list provided by the manufacturer to determine if their device is affected.

The recalled product

Product: 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.
Manufacturer: Animas Corporation
Category: Medical Device — Insulin Pump
Hazard: false-alarm

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 (9)

Part Numbers 101370-00
101371-00
101372-00
101374-00
101375-00
100380-00
100381-00
100382-00
100384-00

Distribution

Distributed nationwide across the United States.

The notice also names 47 states specifically:

Same manufacturer · Animas Corporation

See all →

Severe
Animas Vibe Insulin Pump Recalled Due to Calibration Factor Overwrite
FDA (Devices) · 2015-02-11
Moderate
Animas Vibe Insulin Infusion Pump Recalled for Keypad Wear Issues
FDA (Devices) · 2014-11-05
Moderate
Animas Vibe Insulin Pump Recalled for Incorrect Hebrew Translation
FDA (Devices) · 2014-11-05
High
Animas Insulin Pumps Cease Operation Due to Calendar Date Limit
FDA (Devices) · 2013-02-27
Moderate
Animas Insulin Pumps Recalled for Keypad Wear and Peeling
FDA (Devices) · 2012-10-10

Same hazard · false alarm