Roche Diagnostics Operations, Inc.: 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 indwe

Is my product affected?

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 through the injection por

• UPC 04541456001

Check against the official notice below — it lists the full affected range.

What happened

Roche Diagnostics Operations, Inc. is recalling ACCU-CHEK Tender II 13/110 10 + 10 pieces infusion sets used to deliver insulin below the skin's surface. The manufacturer UnoMedical identified a potential defect where tubing can detach at the connection point on both ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets. When detachment occurs, insulin delivery stops but the insulin pump does not sound an alarm to alert the user that delivery has been interrupted.

The recalled product was distributed nationwide in the United States, affecting a total of 13,041 boxes with catalog number 04541456001 and lot number 5052067. The recall record does not specify what remedy consumers should pursue.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the the tubing of the infusion set to become detached at the connect/disconnect location on the ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets. If tubing detachment occurs, insulin delivery is interrupted and the pump will not alarm to notify

Details from the source

Reason for recall: Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the the tubing of the infusion set to become detached at the connect/disconnect location on the ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets. If tubing detachment occurs, insulin delivery is interrupted and the pump will not alarm to notify Distribution: US Nationwide Distribution Quantity: Total of 13,041 boxes Lot/code info: Catalog: 04541456001 and lot: 5052067

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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