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) interrupts 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 Diabetes Care is recalling ACCU-CHEK Tender II infusion sets manufactured by UnoMedical. The recall involves a total of 13,041 boxes distributed nationwide in the United States. The affected products are identified by catalog number 04541502001 and lot numbers 5044353, 5046676, 5053301, and 5061934.
The recall was initiated because the tubing of the infusion set may 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. This lack of alarm means the user may not be aware that insulin is no longer being delivered.
Consumers should check their infusion sets for the specific catalog and lot numbers listed above. If the product matches the recalled items, users should stop using the infusion sets and contact Roche Diabetes Care or their healthcare provider for instructions on replacement or further action.
The recalled product
- Product
- ACCU-CHEK Tender II 17/60 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 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: 04541502001 and lots: 5044353
- 5046676
- 5053301
- and 5061934.
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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