Z-0279-06

StrykeFlow II Disposable Suction/Irrigator; AHTO Tube Set; Model Numbers: 250-070-500, 250-070-520...

Name: Z-0279-06 StrykeFlow II Disposable Suction/Irrigator; AHTO Tube Set; Model Numbers: 250-070-500, 250-070-520...
Creator: Stryker Endoscopy
Published: 2005-11-18
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2005-11-18 / Terminated / root cause: packaging

FDA source

Stryker Endoscopy began a recall of StrykeFlow II Disposable Suction/Irrigator; AHTO Tube Set; Model Numbers: 250-070-500, 250-070-520, 250-070-540, 250-070-600, 250-070-620; Product is... on 2005-11-18. The reason FDA records is "Devices for which sterility may be compromised as evidenced by a crack in the package". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0279-06
Status: Terminated
Initiated: 2005-11-18
Posted: 2005-12-14
Terminated: 2006-11-02
Recalling firm: Stryker Corp.
Product: StrykeFlow II Disposable Suction/Irrigator; AHTO Tube Set; Model Numbers: 250-070-500, 250-070-520, 250-070-540, 250-070-600, 250-070-620; Product is distributed by Stryker Endoscopy, 5900 Optical Court San Jose, CA 95138
Product code: GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Reason for recall: Devices for which sterility may be compromised as evidenced by a crack in the package.
Root cause tag: packaging
FDA root cause: Other
Action: On 11/18/05, the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be returned.
Quantity in commerce: 48405 boxes, 6 units per box
Distribution: The product was distributed nationally to 1321 consignees and internationally to 18 consignees.
Product codes and lots: Lots 05258FG2 through 05299FG2; ***On 1/6/06 Lot Code bracket expanded: 05151FG2 through 05299FG2***

Product code GCX

K042454Class IIStryker Cassette PumpStryker Endoscopy / cleared 2004-12-09

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)