Asante Comfort Infusion Set with 110cm tubing & 13mm recall
Asante Comfort Infusion Set with 110cm tubing & 13mm cannula packaged in 5-packs,singles, or inside a Combination Kit (FG-5143-4). Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical Lejre, Denmark
Why was Asante Comfort Infusion Set with 110cm tubing & 13mm 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-4143-5, FG-4143T. Unomedical Item number: 87-110-2562 Lot numbers: 0230120; 0230124 5031108.
- Product
- Asante Comfort Infusion Set with 110cm tubing & 13mm cannula packaged in 5-packs,singles, or inside a Combination Kit (FG-5143-4). Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical Lejre, Denmark
- Recalling firm
- Asante Solutions, Inc.
- Quantity
- 635 kits
- Distribution
- Nationwide Distribution.
- Recall date
- January 8, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)