Z-0926-2009

Stryker PainPump 2 Blockaid, 400 mL PainPump for Continuous Nerve Block, sterile, 5 per box. Stryker...

Name: Z-0926-2009 Stryker PainPump 2 Blockaid, 400 mL PainPump for Continuous Nerve Block, sterile, 5 per box. Stryker...
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2008-11-12
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2008-11-12 / Terminated / root cause: manufacturing process

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of Stryker PainPump 2 Blockaid, 400 mL PainPump for Continuous Nerve Block, sterile, 5 per box. Stryker, Kalamazoo, MI; REF 575-100, Product Number 0575-100-000... on 2008-11-12. The reason FDA records is "The pump may display an E-4 error message, which causes the pump to stop dispensing the pain medication". 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-0926-2009
Status: Terminated
Initiated: 2008-11-12
Posted: 2009-01-27
Terminated: 2009-11-30
Recalling firm: Stryker Corp.
Product: Stryker PainPump 2 Blockaid, 400 mL PainPump for Continuous Nerve Block, sterile, 5 per box. Stryker, Kalamazoo, MI; REF 575-100, Product Number 0575-100-000. The device is used to deliver controlled amounts of medication and narcotics directly to the intraoperative site for pain management, the pump infuses the medication at an hourly flow rate and provides the option for patient controlled bolus doses. Medications and narcotics are infused through intramuscular, subcutaneous and epidural routs. It is also intended for controlled delivery of local anesthetics and narcotics in close proximity to nerves for postoperative regional anesthesia and pain management, in which case routes of administration may be intraoperative, perineural or percutaneous.
Product code: FRN Pump, Infusion
Reason for recall: The pump may display an E-4 error message, which causes the pump to stop dispensing the pain medication.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Consignees were notified via letter dated 11/12/08 and instructed to locate and destroy the affected lots. Customers were also instructed to complete and return the enclosed Business Reply form via fax (336-499-8603) to Stryker Instruments Regulatory Department. For questions regarding the recalled product, please contact Stryker Instruments at 1-800-800-4236, extension 3808 or extension 4056.
Quantity in commerce: 2,009 boxes
Distribution: Worldwide Distribution including USA and country of Canada.
Product codes and lots: Lot Numbers: 08219012, 08220012, 08221012, 08222012, 08225012, 08226012, 08229012, 08231022, 08233012, 08234012, 08235012, 08238022, 08239012, 08241012, 08242012, 08243012, 08246022, 08247012, 08249032, 08250012, 08252022, 08252032, 08253012, 08254012, 08256032, 08256042, 08257012 and 08259022.

Product code FRN

K043466Class IIPainpump2Stryker Instruments / cleared 2005-05-10

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)