Z-0668-06

Stryker PainPump1.5 Base Infusion Kit; Product number 501-100-000

Name: Z-0668-06 Stryker PainPump1.5 Base Infusion Kit; Product number 501-100-000
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2006-02-03
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2006-02-03 / Terminated

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of Stryker PainPump1.5 Base Infusion Kit; Product number 501-100-000 on 2006-02-03. The reason FDA records is "The catheter tubing included in the kit may break during removal". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0668-06
Status: Terminated
Initiated: 2006-02-03
Posted: 2006-03-21
Terminated: 2007-06-04
Recalling firm: Stryker Corp.
Product: Stryker PainPump1.5 Base Infusion Kit; Product number 501-100-000.
Product code: MEA Pump, Infusion, Pca
Reason for recall: The catheter tubing included in the kit may break during removal.
FDA root cause: Other
Action: Each consignee was notified of the recall via recall letter dated 2/7/06, which requested that they destroy the affected lots on site. International accounts were notified via email.
Distribution: Nationwide, Australia and Canada.
Product codes and lots: Lot 2005053004.

Product code MEA

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)