Roche Diagnostics Operations, Inc.: 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 indwel

Is my product affected?

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 through the injection port

• UPC 04541502001

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

What happened

Roche Diagnostics Operations, Inc. has recalled ACCU-CHEK Tender II 17/60 10 + 10 pieces infusion sets distributed nationwide. The recall was initiated after the manufacturer, UnoMedical, informed Roche Diabetes Care that the tubing in these infusion sets could potentially detach at the connect/disconnect location. A total of 13,041 boxes were affected, specifically those with catalog number 04541502001 and lot numbers 5044353, 5046676, 5053301, and 5061934.

If tubing detachment occurs in these infusion sets, insulin delivery would be interrupted. The pump will not alarm to alert the user that delivery has stopped, meaning the interruption could go unnoticed. 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: 04541502001 and lots: 5044353, 5046676, 5053301, and 5061934.

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 17/80 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

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