Z-0924-2009

Stryker PainPump Two Site Infusion Kit with ExFen 5.0", 120 mL Infusion Kit, sterile, 5 per box. Manufactured...

Name: Z-0924-2009 Stryker PainPump Two Site Infusion Kit with ExFen 5.0", 120 mL Infusion Kit, sterile, 5 per box. Manufactured...
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2008-11-07
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2008-11-07 / Terminated / root cause: manufacturing process

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of Stryker PainPump Two Site Infusion Kit with ExFen 5.0", 120 mL Infusion Kit, sterile, 5 per box. Manufactured for Stryker Instruments, Kalamazoo, MI. Product... on 2008-11-07. The reason FDA records is "There is a potential for the pump to overinfuse". 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-0924-2009
Status: Terminated
Initiated: 2008-11-07
Posted: 2009-02-02
Terminated: 2009-12-01
Recalling firm: Stryker Corp.
Product: Stryker PainPump Two Site Infusion Kit with ExFen 5.0", 120 mL Infusion Kit, sterile, 5 per box. Manufactured for Stryker Instruments, Kalamazoo, MI. Product number 0500-166-050, REF 500-166-50. A disposable syringe infuser which uses sustained vacuum pressure to deliver a continuous infusion of medications or fluids at a controlled rate. It delivers controlled amounts of medication directly to the intraoperative site for pain management and/or antibiotic administration. It is also intended for controlled delivery of local anesthetics in close proximity to nerves for postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, or percutaneous.
Product code: FRN Pump, Infusion
Reason for recall: There is a potential for the pump to overinfuse.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: A "Medical Device Recall Notification" letter dated November 11, 2008 was issued to consignees. The letter identified the problem and instructed consignees to locate and destroy all affected products. Customers were also instructed to complete the enclosed Business Reply form and fax it to Stryker Instruments Regulatory Department at 866-521-2760. For questions regarding the recalled product, contact Stryker Instruments at 1-800-800-4236, extension 4056 or extension 3808.
Quantity in commerce: 118 boxes of all products.
Distribution: Nationwide Distribution.
Product codes and lots: Lot Number: 2008011404 and 2008050201.

Product code FRN

K042405Class IIPainpump1; Painpump2Stryker Corp. / cleared 2004-10-14

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)