Z-2594-2010

Stryker PainPump2 BlockAid Demo 400 mL PainPump for Continuous Nerve Block, Non-sterile Not for surgical use...

Name: Z-2594-2010 Stryker PainPump2 BlockAid Demo 400 mL PainPump for Continuous Nerve Block, Non-sterile Not for surgical use...
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2010-09-02
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2010-09-02 / Terminated / root cause: manufacturing process

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of Stryker PainPump2 BlockAid Demo 400 mL PainPump for Continuous Nerve Block, Non-sterile Not for surgical use, REF 575-100S1, Stryker Instruments, Kalamazoo... on 2010-09-02. The reason FDA records is "All of the failures lead to the patient receiving less medication than intended. Certain lots of the pain pump have a high failure rate associated with a cracked port housing which leads to internal or external leaks...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2594-2010
Status: Terminated
Initiated: 2010-09-02
Posted: 2010-09-28
Terminated: 2011-04-21
Recalling firm: Stryker Corp.
Product: Stryker PainPump2 BlockAid Demo 400 mL PainPump for Continuous Nerve Block, Non-sterile Not for surgical use, REF 575-100S1, Stryker Instruments, Kalamazoo, MI. Delivers controlled amounts of medication and narcotics.
Product code: FRN Pump, Infusion
Reason for recall: All of the failures lead to the patient receiving less medication than intended. Certain lots of the pain pump have a high failure rate associated with a cracked port housing which leads to internal or external leaks. Some lots have a high failure rate associated with E2 errors.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm sent our Urgent Medical Device Recall Notices dated 7/12/2010 to Risk Managers and Materials Managers. The recall notice listed specific lots of PainPump2 and PainPump2 BlockAid that were under recall. Consignees were told to check stock for the recalled product, quarantine the product, and contact Stryker to arrange return shipment of the recalled product. On 9/2/2010 the firm sent out a second Urgent Medical Device Recall Notice. This notice expanded the scope of the recall to include all products distributed within the past 12 months. The shelf life of the product is 1 year -so the recall was for all product currently in the supply chain. The letter again directed consignees to locate the recalled products and contact Stryker to arrange return shipment of the recalled product. The firm sent an additional letter dated 9/1/2010 to its customers. This letter stated that Stryker will no longer be offering any of their PainPump2 products.
Quantity in commerce: 54,568 all products
Distribution: Worldwide Distribution -- US, Canada, and Australia.
Product codes and lots: 09237012, 09301012, 10040012, and 10049012.

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)