Z-1130-2007

Cleaning probe included as an accessory to aspirators that are sterile packed single use disposable...

Name: Z-1130-2007 Cleaning probe included as an accessory to aspirators that are sterile packed single use disposable...
Creator: GE OEC Medical Systems, Inc
Published: 2007-05-18
License: https://open.fda.gov/license/

GE Healthcare / initiated 2007-05-18 / Terminated

FDA source

GE OEC Medical Systems, Inc began a recall of Cleaning probe included as an accessory to aspirators that are sterile packed single use disposable accessories to the GE InstaTrak 3500 Plus x-ray system... on 2007-05-18. The reason FDA records is "Cleaning probes used to unclog disposable aspirators may shed small particles of nylon material which may be transferred into the nasal cavity". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1130-2007
Status: Terminated
Initiated: 2007-05-18
Posted: 2007-08-07
Terminated: 2011-08-22
Recalling firm: GE Healthcare
Product: Cleaning probe included as an accessory to aspirators that are sterile packed single use disposable accessories to the GE InstaTrak 3500 Plus x-ray system. Probes are packaged and shipped together with the following aspirators: Straight Aspirator - 1000370-NAV, 7 French Aspirator - 100936, Keane - Moses Extended Straight Aspirator - 1000748, 15 degree aspirator - 1003895, Fried 45 Degree Aspirator - 1000541, Kuhn 90 degree Aspirator - 1000543-NAV.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Cleaning probes used to unclog disposable aspirators may shed small particles of nylon material which may be transferred into the nasal cavity.
FDA root cause: Other
Action: Consignees were notified by certified mail on 05/18/2007 and were told to stop using and to dispose of the affected probes.
Quantity in commerce: 67,625 units
Distribution: Worldwide, including USA, Canada and France.
Product codes and lots: No manufacturing or serial numbers.

Product code LLZ

K960330Class IIInstatrakVisualization Technology, Inc. / cleared 1996-04-08

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)