FDA Medical Device Recalls (openFDA)
Animas Corporation: 2.0 mL Cartridge/Syringe Piston component of Insulin Pump Insulin infusion
- Recall number
- Z-1678-2011
- Recalling firm
- Animas Corporation
- Product
- 2.0 mL Cartridge/Syringe Piston component of Insulin Pump Insulin infusion
- Status
- Terminated
- Initiated
- 2011-02-25
- Posted
- 2011-05-10
- Terminated
- 2014-04-03
- Reason
- Action is being undertaken to address the occurrence of adverse events associated with leaking cartridges. Firm became aware of this issue through customer complaints from pump users reporting the cartridges were leaking.
- Root cause
- Material/Component Contamination
- Action
- Animas Corporation sent an Urgent Recall letter dated February 22, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to: Change their cartridge immediately using the instructions provided. Return all of the unused affected product using the enclosed box. Shipments must be returned using the United States Postal Service. For technical questions call Animas Customer Support at 1-855-254-5668 or call the toll free number at 1-8777-937-7867. For any questions about returning the product call 1-877-280-2339. Customers were instructed to notify the firm by logging on to the following website: www.animasnotification.com or call the Call Center at 1-877-280-2339 if they have no product to return.
- Quantity
- 384,180
- Distribution
- Worldwide Distribution - USA (nationwide) and France.
- Lot, serial or model codes
- Lot numbers -- US: B201575, B201576, B201581, B201582, Exp. 7/31/2012; B201583, Exp. 8/31/2012; FRANCE: B201580, Exp. 7/31/2012.
- 510(k) numbers
- ["K032257"]
- PMA numbers
- not on file
- Product code
- LZG
- Firm FEI
- 3002920072
- Firm city
- West Chester
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28