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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling 13,041 boxes of ACCU-CHEK Tender II 13/110 infusion sets (Catalog 04541456001, Lot 5052067). The product was distributed nationwide in the United States. 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 product is intended for the infusion and/or injection of fluids into the body below the surface of the skin.
Consumers who have these specific infusion sets should stop using them and contact Roche Diagnostics for further instructions.
The recalled product
- Product
- ACCU-CHEK Tender II 13/110 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…
- 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: 04541456001 and lot: 5052067
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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