Z-0594-2014 Class II Terminated
FDA device recall Z-0594-2014 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: 834 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
- 834 kits
Product Description
Asante Comfort Infusion Set with 60cm tubing & 13mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5123-4) Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical 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-4123-5 FG-4123T Unomedical Item number: 87-060-2562; Lot numbers: 0230118 0230122 5036994