ACCU-CHEK Tender II 17/80 10 + 10 pieces Product Usage recall
ACCU-CHEK Tender II 17/80 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the…
Why was ACCU-CHEK Tender II 17/80 10 + 10 pieces Product Usage recalled?
Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the the tubing of the infusion set to become detached at the connect/disconnect location on the ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets. If tubing detachment occurs, insulin delivery is interrupted and the pump will not alarm to notify
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?
Catalog: 04541529001 and lots: 5044354, 5051306, 5058507, and 5062209.
- Product
- ACCU-CHEK Tender II 17/80 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the…
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Quantity
- Total of 13,041 boxes
- Distribution
- US Nationwide Distribution
- Recall date
- January 7, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)