Z-1788-2009

Stryker PainPump ExFen, 10.0 in. dual site antimicrobial silver ExFen catheter, sterile, Stryker Instruments...

Name: Z-1788-2009 Stryker PainPump ExFen, 10.0 in. dual site antimicrobial silver ExFen catheter, sterile, Stryker Instruments...
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2009-06-16
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2009-06-16 / Terminated / root cause: manufacturing process

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of Stryker PainPump ExFen, 10.0 in. dual site antimicrobial silver ExFen catheter, sterile, Stryker Instruments, Kalamazoo, MI; REF 0555-210-000 on 2009-06-16. The reason FDA records is "The catheter may break when removed from the body, or the catheter may have kinks or be occluded such that the patient will not receive the intended quantity of 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-1788-2009
Status: Terminated
Initiated: 2009-06-16
Posted: 2009-08-19
Terminated: 2010-10-27
Recalling firm: Stryker Corp.
Product: Stryker PainPump ExFen, 10.0 in. dual site antimicrobial silver ExFen catheter, sterile, Stryker Instruments, Kalamazoo, MI; REF 0555-210-000.
Product code: FRN Pump, Infusion
Reason for recall: The catheter may break when removed from the body, or the catheter may have kinks or be occluded such that the patient will not receive the intended quantity of medication.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Stryker Instruments issued a recall letter dated June 16, 2009 and instructed Consignees to cease using and destroy the product and to return a business reply form for credit via fax to Stryker Instruments Regulatory Department, 1-866-521-2762. For further questions, contact Stryker Instruments at 1-800-800-4236 extension 3808.
Quantity in commerce: 65
Distribution: Worldwide Distribution -- Including the United States, Argentina, Australia, Brazil, Canada, England, France, Germany, Hong Kong, Italy, Japan, Latin America, Malaysia, Mexico, Netherlands, New Zealand, Singapore, South Africa, Spain, Sweden, Switzerland and Taiwan.
Product codes and lots: Lot Numbers: 2008062601 through 2008062601.

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)