ACCU-CHEK Tender II Infusion Sets Recalled for Tubing Detachment Risk
Roche Diagnostics is recalling ACCU-CHEK Tender II 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 the patient. This fits the rubric for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling 13,041 boxes of ACCU-CHEK Tender II 13/80 10 + 10 pieces infusion sets. The recall involves catalog number 04541472001 and lots 5053291 and 5078661. These products were distributed nationwide in the United States.
The recall was initiated after UnoMedical, the manufacturer of the infusion sets, informed Roche Diabetes Care of a potential for the tubing to become detached at the connect/disconnect location. If this detachment occurs, insulin delivery is interrupted, and the pump will not alarm to notify the user.
Consumers should stop using the affected infusion sets immediately. The source text does not specify additional consumer instructions or contact information for returns or replacements.
The recalled product
- Product
- ACCU-CHEK Tender II 13/80 10 + 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 th
- 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: 04541472001 and lots: 5053291 and 5078661.
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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