Z-1184-2009

Stryker PainPump2, 250 mL PainPump with 2.5 inch ExFen Catheter and Luer Lock Tubing Set, 5 per box, sterile...

Name: Z-1184-2009 Stryker PainPump2, 250 mL PainPump with 2.5 inch ExFen Catheter and Luer Lock Tubing Set, 5 per box, sterile...
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2009-02-11
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2009-02-11 / Terminated / root cause: manufacturing process

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of Stryker PainPump2, 250 mL PainPump with 2.5 inch ExFen Catheter and Luer Lock Tubing Set, 5 per box, sterile, Stryker, Kalamazoo, MI; REF 525-158. The Stryker... on 2009-02-11. The reason FDA records is "An electronic failure during preparation of the unit, or during patient use, may cause the pump to shut down". 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-1184-2009
Status: Terminated
Initiated: 2009-02-11
Posted: 2009-04-30
Terminated: 2009-12-01
Recalling firm: Stryker Corp.
Product: Stryker PainPump2, 250 mL PainPump with 2.5 inch ExFen Catheter and Luer Lock Tubing Set, 5 per box, sterile, Stryker, Kalamazoo, MI; REF 525-158. The Stryker PainPump2 is an electromechanical pump designed to deliver a controlled amount of medication to the patient for pain management.
Product code: FRN Pump, Infusion
Reason for recall: An electronic failure during preparation of the unit, or during patient use, may cause the pump to shut down.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: A "Medical Device Recall Notification" letter dated February 11, 2009 was issued to consignees via phone, mail and/or email. The letter described the issue and instructed customers to discontinue use of the recalled product, destroy it according to instructions provided with the notification and return the "Business Reply Form" by fax to Stryker Instruments Regulatory Department, 1-866-521-2762. Further questions should be addressed to Stryker Instruments at 1-800-800-4236 extension 4086.
Quantity in commerce: 24,675 pumps
Distribution: Worldwide Distribution -- USA including states of AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, WA, WI, WV and WY and countries of Argentina, Australia, Brazil, Canada, England, Singapore and South Africa.
Product codes and lots: Lot Number: 08316012.

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)