Z-1177-06

Stryker brand Insufflation Tube Set and High Flow Insufflation Tube Set, Model Numbers: 620-030-201...

Name: Z-1177-06 Stryker brand Insufflation Tube Set and High Flow Insufflation Tube Set, Model Numbers: 620-030-201...
Creator: Stryker Endoscopy
Published: 2006-06-02
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2006-06-02 / Terminated / root cause: packaging

FDA source

Stryker Endoscopy began a recall of Stryker brand Insufflation Tube Set and High Flow Insufflation Tube Set, Model Numbers: 620-030-201, 620-030-301 on 2006-06-02. The reason FDA records is "Device for which sterility may be compromised as evidenced by a loss of package integrity". 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-1177-06
Status: Terminated
Initiated: 2006-06-02
Posted: 2006-06-27
Terminated: 2006-11-20
Recalling firm: Stryker Corp.
Product: Stryker brand Insufflation Tube Set and High Flow Insufflation Tube Set, Model Numbers: 620-030-201, 620-030-301
Product code: HET Laparoscope, Gynecologic (And Accessories)
Reason for recall: Device for which sterility may be compromised as evidenced by a loss of package integrity.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: On 6/2/06, the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be returned.
Distribution: Nationwide
Product codes and lots: Lots 04051142--06121FE2, 04051142--06123FE2

Product code HET

K943508Class IIInsufflator Tubing with FilterStryker Endoscopy / cleared 1994-11-17

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)