Z-0891-2015Class II

ACCU-CHEK Tender II 13/110 10 + 10 pieces

Name: Z-0891-2015 ACCU-CHEK Tender II 13/110 10 + 10 pieces
Creator: Roche Diagnostics Operations, Inc.
Published: 2014-11-20
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2014-11-20 / Terminated / root cause: design

FDA source

Roche Diagnostics Operations, Inc. began a recall of ACCU-CHEK Tender II 13/110 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The... on 2014-11-20. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0891-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-20
Posted: 2014-12-30
Terminated: 2018-01-10
Recalling firm: Roche Diagnostics GmbH
Product: ACCU-CHEK Tender II 13/110 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. 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.
Product code: FPA Set, Administration, Intravascular
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
Root cause tag: design
FDA root cause: Device Design
Action: Roche sent the "Urgent Medical Device Corrections" letter dated 12/1/2014 via UPS Ground (receipt required) to the Patients, and Distributors who received the affected device. The letter included a description of the reason for recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. No product returns were expected. For questions, contact the ACCU-CHEK Pump Support at 1-800-688-4578.
Quantity in commerce: Total of 13,041 boxes
Distribution: US Nationwide Distribution
Product codes and lots: Catalog: 04541456001 and lot: 5052067

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0891-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0883-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-07	2014-12-30
Z-0884-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-07	2014-12-30
Z-0885-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-07	2014-12-30
Z-0886-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-07	2014-12-30
Z-0887-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-07	2014-12-30
Z-0888-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-07	2014-12-30
Z-0889-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-07	2014-12-30
Z-0890-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-07	2014-12-30
Z-0891-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-07	2014-12-30
Z-0892-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-07	2014-12-30
Z-0893-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-07	2014-12-30
Z-0894-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-07	2014-12-30

Product code FPA

K972135Class IIMaersk Medical Pureline Comfort Subcutaneous Infusion SetP/L Biomedical / cleared 1997-08-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)