Z-0096-2011

Stryker PainPump2 250 mL Painpump with Luer Lock Tubing Set, REF 525-350, Sterile, Rx only, Stryker...

Name: Z-0096-2011 Stryker PainPump2 250 mL Painpump with Luer Lock Tubing Set, REF 525-350, Sterile, Rx only, Stryker...
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2010-08-16
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2010-08-16 / Terminated / root cause: labeling and UDI

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of Stryker PainPump2 250 mL Painpump with Luer Lock Tubing Set, REF 525-350, Sterile, Rx only, Stryker Instruments, Kalamazoo, MI on 2010-08-16. The reason FDA records is "The instructions for use (IFU) has been revised for health care professionals. The indication for use has been changed to remove site specific pain management. The firm has revised the warning to not use the pump around...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0096-2011
Status: Terminated
Initiated: 2010-08-16
Posted: 2010-10-20
Terminated: 2011-04-21
Recalling firm: Stryker Corp.
Product: Stryker PainPump2 250 mL Painpump with Luer Lock Tubing Set, REF 525-350, Sterile, Rx only, Stryker Instruments, Kalamazoo, MI.
Product code: FRN Pump, Infusion
Reason for recall: The instructions for use (IFU) has been revised for health care professionals. The indication for use has been changed to remove site specific pain management. The firm has revised the warning to not use the pump around joint spaces. A warning has been added regarding the use of the pump with anticoagulants in epidural applications. A special reminder to users to always evaluate the potential
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Stryker Instruments sent Urgent Medical Device Recall Notification letters dated 8/16/2010 to healthcare professionals. The recall letters outlined the changes for the instructions for the use of these products. The letters informed the healthcare professional to review the new IFU, to distribute the new IFU to all healthcare professionals that use the device, and to complete and return the business reply form. The letters included a complete IFU that was to be used with any remaining stock of devices. Customers should dispose of the old version of the IFU. There is no product being returned for this recall.
Quantity in commerce: 11,976 all products
Distribution: US, Canada and Australia.
Product codes and lots: '09160012, '09163012, '09176012, '09197012, '09198012, '09203012, '09211012, '09213022, '09217012, '09222012, '09230012, '09234012, '09241012, '09246012, '09258012, '09262012, '09283012, '09289012, '09290012, '09292022, '10012012, '10013012, '10014012, '10015012, '10018022, '10019012, '10021012, '10028012, '10029012, '10032022, '10033012, and '10039022.

Product code FRN

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)