Asante Comfort Infusion Set with 110cm tubing & 17mm recall
Asante Comfort Infusion Set with 110cm tubing & 17mm cannula packaged in 5-packs, singles, or inside a Combination Kit (FG-5147-4). Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical, Lejre, Denmark
Why was Asante Comfort Infusion Set with 110cm tubing & 17mm recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Asante Catalog number:FG-4147-5, FG-4147T Unomedical Item number:87-110-2662; Lot numbers: 0230121 0230125 5025227.
- Product
- Asante Comfort Infusion Set with 110cm tubing & 17mm cannula packaged in 5-packs, singles, or inside a Combination Kit (FG-5147-4). Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical, Lejre, Denmark
- Recalling firm
- Asante Solutions, Inc.
- Quantity
- 352
- Distribution
- Nationwide Distribution.
- Recall date
- January 8, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)