Roche Diagnostics Operations, Inc.: 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

Is my product affected?

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. The

• UPC 04541391001

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

What happened

ACCU-CHEK Tender I and Tender II infusion sets are being recalled because the tubing can become detached at the connect/disconnect location. These infusion sets are used to deliver insulin below the skin's surface. The recall affects 13,041 boxes distributed nationwide, with catalog number 04541391001 and lot number 5062206.

When tubing detachment occurs, insulin delivery stops but the pump does not alarm to alert the user to the problem. The source document does not specify a remedy or what affected consumers should do.

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: 04541391001 and lot: 5062206.

Source

Official record: FDA (Device enforcement) ↗

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

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• ACCU-CHEK Tender I 17/110 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

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