Home / Recalls / Asante Solutions, Inc. / Z-0594-2014

Z-0594-2014 Class II Terminated

Recalled by Asante Solutions, Inc. — Sunnyvale, CA

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

Other recalls by Asante Solutions, Inc.

  • Z-0597-2014 Class II — Asante Comfort Infusion Set with 110cm tubing & 17mm cannula packaged in 5-pack (November 19, 2013)
  • Z-0598-2014 Class II — Asante Conset Infusion Set with 60cm tubing & 6mm cannula packaged in 5-packs,si (November 19, 2013)
  • Z-0595-2014 Class II — Asante Comfort Infusion Set with 60cm tubing & 17mm cannula packaged in 5-packs, (November 19, 2013)
  • Z-0596-2014 Class II — Asante Comfort Infusion Set with 110cm tubing & 13mm cannula packaged in 5-packs (November 19, 2013)
  • Z-0601-2014 Class II — Asante Conset Infusion Set with tubing & 9mm cannula packaged in 5-packs,singles (November 19, 2013)
  • Z-0599-2014 Class II — Asante Conset Infusion Set with 60cm tubing & 9mm cannula packaged in 5-packs,si (November 19, 2013)
  • Z-0600-2014 Class II — Asante Conset Infusion Set with 110cm tubing & 6mm cannula packaged in 5-packs, (November 19, 2013)