Roche Recalls ACCU-CHEK Tender I Infusion Sets Due to Tubing Detachment Risk
Roche Diagnostics is recalling ACCU-CHEK Tender I infusion sets because the tubing may detach, interrupting insulin delivery without an alarm.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where a defect (tubing detachment) interrupts insulin delivery without an alarm, posing a risk of harm to the user, but the source text does not report specific injuries or illnesses.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling 13,041 boxes of ACCU-CHEK Tender I 17/80 infusion sets. The recall was initiated after the manufacturer, UnoMedical, identified a potential for the tubing to become detached at the connect/disconnect location on the infusion sets.
If the tubing detaches, insulin delivery is interrupted. The source text notes that the pump will not alarm to notify the user if this detachment occurs. The affected product is intended for the infusion and/or injection of fluids into the body below the surface of the skin.
The recall covers catalog number 04541448001 and lots 5040426, 5044368, 5051312, and 5058506. The product was distributed nationwide in the United States. Consumers should check their product lot numbers and contact the recalling firm for instructions.
The recalled product
- Product
- ACCU-CHEK Tender I 17/80 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections through
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Affected units
- 13,041
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Catalog: 04541448001 and lots: 5040426
- 5044368
- 5051312
- and 5058506.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by Roche Diagnostics Operations, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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