Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of in
FDA device recall Z-0993-2013 · posted 2013-04-03 · Terminated
Recall details
- Recalling firm
- Animas Corporation
- Reason for recall
- 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.
- Action taken
- Animas sent an Urgent Recall letter dated December 17, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter informed customers that Animas will send a replacement pump free of charge, along with instructions for returning their pump. For questions or concerns contact at 866-796-6373.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LZG
- Quantity affected
- 7,157 (494 US pumps affected)
- Distribution
- Worldwide Distribution - USA (nationwide) including the states of: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, O
- Date initiated
- 2013-01-03
- Date posted
- 2013-04-03
- Date terminated
- 2015-05-14
- Location
- West Chester, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ANIMAS MODEL IR1250 INSULIN INFUSION PUMP (K042873) | Animas Corp. | 2004-12-10 |