Roche Diagnostics Operations, Inc.: 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 indw

Is my product affected?

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 po

• UPC 04541405001

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

What happened

Roche Diagnostics Operations, Inc. is recalling ACCU-CHEK Tender I 13/60 10-piece infusion sets distributed nationwide in the United States. The infusion sets are used to deliver insulin under the skin. According to the manufacturer UnoMedical, the tubing on these devices can become detached at the connection point, which would stop insulin delivery. If detachment occurs, the pump will not alarm to alert the user that insulin is no longer being delivered. A total of 13,041 boxes with catalog number 04541405001 and lot numbers 5044359 or 5061929 are affected.

The recall notice does not specify what consumers should do if they have this product.

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: 04541405001 and Lots: 5044359, 5061929

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 13/80 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
• 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

All FDA (Device enforcement) recalls