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 significant risk of harm to patients, but the source text does not report specific injuries or fatalities.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling 13,041 boxes of ACCU-CHEK Tender I 13/60 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 products are identified by Catalog 04541405001 and Lots 5044359 and 5061929.
These infusion sets were distributed nationwide in the United States. Consumers should stop using the affected infusion sets and contact Roche Diagnostics for further instructions or a replacement.
The recalled product
- Product
- ACCU-CHEK¿ Tender I 13/60 10 pieces Product Usage: 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
- 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 (2)
- Catalog: 04541405001 and Lots: 5044359
- 5061929
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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