Roche Diagnostics Operations, Inc.: 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 indwel

Is my product affected?

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 through the injection port

• UPC 04541529001

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

What happened

Roche Diagnostics Operations, Inc. has recalled ACCU-CHEK Tender II 17/80 10 + 10 piece infusion sets distributed nationwide. The recall was initiated after the manufacturer, UnoMedical, informed Roche Diabetes Care that the tubing on these infusion sets has the potential to become detached at the connect/disconnect location. The affected products include Catalog Number 04541529001 in lots 5044354, 5051306, 5058507, and 5062209, with a total of 13,041 boxes recalled.

If tubing detachment occurs during use of these infusion sets, insulin delivery will be interrupted. The recall notice indicates that the pump will not alarm to notify the user of the delivery interruption, meaning patients could be unaware that they are not receiving insulin. The source document does not specify what remedy or action affected consumers should take.

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: 04541529001 and lots: 5044354, 5051306, 5058507, and 5062209.

Source

Official record: FDA (Device enforcement) ↗

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

Related recalls

• ACCU-CHEK¿ Tender I 13/60 10 pieces Product Usage: 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 po2014-11-20
• ACCU-CHEK Tender I 13/80 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 port. The 2014-11-20
• ACCU-CHEK Tender I 13/110 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 port. The2014-11-20
• ACCU-CHEK Tender I 17/60 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 port. The 2014-11-20
• ACCU-CHEK Tender I 17/80 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 port. The 2014-11-20

All FDA (Device enforcement) recalls