CLASS II Device recall · Reported 7 Jan 2015 · FDA Enforcement Report
Accu-chek Tender I 17/60 recalled by Roche Diagnostics Operations
Roche Diagnostics Operations is recalling Accu-chek Tender I 17/60, distributed nationwide in the US. The recall was initiated on 20 Nov 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0886-2015
- FDA event ID
- 69821
- Recalling firm
- Roche Diagnostics Operations, Indianapolis, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Nov 2014
- FDA classified
- 30 Dec 2014
- Reported
- 7 Jan 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Heart & Vascular Devices
Timeline
| 20 Nov 2014 | Recall initiated by company | |
| 30 Dec 2014 | Classified by FDA | +40 days |
| 7 Jan 2015 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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 indwelling catheter can also be securely attached to the infusion catheter by means of a proprietary click-lock connector for the infusion of drugs subcutaneously. The infusion set can be detached from the indwelling catheter, and the catheter capped to allow freedom from the infusion set and pump for showers, athletics or other activities.
Where it was distributed
US Nationwide Distribution
Questions about this recall
Is Accu-chek Tender I 17/60 recalled?
Yes. Roche Diagnostics Operations recalled Accu-chek Tender I 17/60 on 20 Nov 2014. The recall is Class II and its status is Terminated. Recall number Z-0886-2015.
Why was it recalled?
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
Which lots are affected?
Catalog: 04541430001 and lots: 5040425, 5044367, 5051305, 5053294, and 5061932.
Where was it sold?
US Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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