Roche Recalls ACCU-CHEK Tender II Infusion Sets Due to Tubing Detachment
Roche Diagnostics is recalling ACCU-CHEK Tender II infusion sets because the 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a medical device defect that interrupts insulin delivery without an alarm, posing a significant risk of harm to patients.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling 13,041 boxes of ACCU-CHEK Tender II 13/60 infusion sets. The recall involves catalog number 04541464001 and lots 5044364 and 5058502. These products were distributed nationwide in the United States.
The recall was initiated after Roche Diabetes Care was informed by UnoMedical, the manufacturer of the infusion sets, about 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 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 13/60 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: 04541464001 and lots: 5044364 and 5058502.
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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