Roche Recalls ACCU-CHEK Tender I Infusion Sets Due to Tubing Detachment Risk
Roche Diabetes Care is recalling ACCU-CHEK Tender I infusion sets because 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 patients, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Roche Diabetes Care is recalling ACCU-CHEK Tender I infusion sets due to a potential defect where the tubing may become detached at the connect/disconnect location. The recall involves 13,041 boxes of the product, specifically catalog number 04541391001 and lot 5062206. These products were distributed nationwide in the United States.
The defect was identified by UnoMedical, the manufacturer of the infusion sets, who informed Roche Diabetes Care of the issue. If the tubing detaches, insulin delivery is interrupted. Additionally, the pump will not provide an alarm to notify the user that the delivery has stopped.
Consumers who have this product should stop using it immediately and contact Roche Diabetes Care for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- ACCU-CHEK Tender I 13/110 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 (1)
- Catalog: 04541391001 and lot: 5062206.
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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