FDA Devices recall · Reported January 7, 2015
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 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
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 s…
Roche Diagnostics Operations, Inc. recalled ACCU-CHEK Tender I 13/80 10 pieces Product Usage: Intended for the infusion and/or in… - a moderate-severity action.
ACCU-CHEK Tender I 13/80 10 pieces Product Usage: Intended for the infusion and/or in… was recalled by Roche Diagnostics Operations, Inc. in January 7, 2015. Reason: Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender I…. Check the official notice for the remedy. Verify recall #Z-0884-2015 with the FDA Devices before acting.
The recall
Roche Diagnostics Operations, Inc. issued this moderate-severity FDA Devices recall-Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender I….
- Moderate
- severity level
- Class II
- classification
- January 7, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0884-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0884-2015) was formally reported on January 7, 2015, with the manufacturer initiating the action on November 20, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Roche Diagnostics Operations, Inc. is listed as the recalling firm, operating out of Indianapolis, IN. Federal records list the affected scope as Total of 13,041 boxes.
The documented reason for this recall is: 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/dis… Distribution data in the federal record shows the product reached: US Nationwide Distribution. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
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 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.
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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0884-2015 |
| Date reported | January 7, 2015 |
| Date initiated | November 20, 2014 |
| Recalling firm | Roche Diagnostics Operations, Inc. |
| Firm location | Indianapolis, IN |
| Affected scope | Total of 13,041 boxes |
| Distribution | US Nationwide Distribution |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0884-2015) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Methodology · Corrections · Archive as of August 2026