Z-0496-03

Trach-Eze Closed Suction System Endotracheal Start Kit * 16F * REF 220070 * Catheter Length: 571 mm *...

Name: Z-0496-03 Trach-Eze Closed Suction System Endotracheal Start Kit *** 16F *** REF 220070 *** Catheter Length: 571 mm ***...
Creator: Sorenson Medical, Inc.
Published: 2002-11-25
License: https://open.fda.gov/license/

Sorenson Medical, Inc. / initiated 2002-11-25 / Terminated

FDA source

Sorenson Medical, Inc. began a recall of Trach-Eze Closed Suction System Endotracheal Start Kit *** 16F *** REF 220070 *** Catheter Length: 571 mm *** STERILE *** on 2002-11-25. The reason FDA records is "Catheters have 2 unvalidated seal product configurations to produce a new hybrid seal that had not been verified or validated". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0496-03
Status: Terminated
Initiated: 2002-11-25
Posted: 2003-01-30
Terminated: 2004-07-12
Recalling firm: Sorenson Medical, Inc.
Product: Trach-Eze Closed Suction System Endotracheal Start Kit *** 16F *** REF 220070 *** Catheter Length: 571 mm *** STERILE ***.
Product code: BSY Catheters, Suction, Tracheobronchial
Reason for recall: Catheters have 2 unvalidated seal product configurations to produce a new hybrid seal that had not been verified or validated.
FDA root cause: Other
Action: On 10/25/2002, all consignees were notified by letter.
Quantity in commerce: 2790 units
Distribution: Distributors in IL, OH, PA. Foreign distribution to Brazil, Czech Republic, Denmark, Guatemala, Italy.
Product codes and lots: Product Code #220070, Lots 206082 and 206106.

Product code BSY

K961707Class ITrach-Eze Closed Ventilation Suction SystemSorenson Critical Care / cleared 1997-03-11

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)