Z-0600-2014 Class II Terminated
FDA device recall Z-0600-2014 was initiated by Asante Solutions, Inc. on November 19, 2013 and is designated Class II. Reason for recall: Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended. The recall status is terminated (terminated April 24, 2014). Affected quantity: 454 kits.
Recall Details
- Product Type
- Devices
- Report Date
- January 8, 2014
- Initiation Date
- November 19, 2013
- Termination Date
- April 24, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 454 kits
Product Description
Asante Conset Infusion Set with 110cm tubing & 6mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5246-4) Distributed by Asante Solutions, Sunnyvale, CA; Manufactured by Convatec; Lejre, Denmark.
Reason for Recall
Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended.
Distribution Pattern
Nationwide Distribution.
Code Information
Asante Catalog number:FG-4246-5, FG-4246T; Unomedical Item number:43-110-5266; Lot numbers: 0230128 5005803 5030168.