Roche Diagnostics Operations, Inc.: 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 c

Is my product affected?

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

• UPC 04541448001

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

What happened

Roche Diagnostics Operations, Inc. is recalling ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets after being informed by the manufacturer, UnoMedical, that the tubing could potentially detach at the connection point. These infusion sets are used to deliver insulin into the body under the skin. A total of 13,041 boxes were distributed nationwide, including specific lot numbers 5040426, 5044368, 5051312, and 5058506 with catalog number 04541448001.

If the tubing becomes detached from the infusion set, insulin delivery would be interrupted. The pump will not alarm to alert the user that insulin is no longer being delivered. The recall notice does not specify what 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: 04541448001 and lots: 5040426, 5044368, 5051312, and 5058506.

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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