Roche Recalls ACCU-CHEK Tender II Infusion Sets Due to Tubing Detachment
Roche 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) can interrupt insulin delivery without an alarm, posing a risk of harm to the patient, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling 13,041 boxes of ACCU-CHEK Tender II 17/80 10 + 10 pieces infusion sets. The recall was initiated after UnoMedical, the manufacturer of the infusion sets, reported a potential for the tubing to become detached at the connect/disconnect location on the ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets.
If the tubing detaches, insulin delivery is interrupted, and the pump will not alarm to notify the user. The affected products were distributed nationwide in the United States. The specific catalog number is 04541529001, and the affected lot numbers are 5044354, 5051306, 5058507, and 5062209.
Consumers should check their infusion sets for these specific catalog and lot numbers. If the product matches the recalled items, they should stop using it and contact Roche Diagnostics Operations, Inc. for instructions on how to return the product or obtain a replacement.
The recalled product
- 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 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 (4)
- Catalog: 04541529001 and lots: 5044354
- 5051306
- 5058507
- and 5062209.
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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