Z-1144-2007

Kimberly Clark Microcuff Endotracheal Tube, Pediatric Oral Curved, sizes 3.0mm, 3.5mm, 4.0mm and 4.5mm, Rx...

Name: Z-1144-2007 Kimberly Clark Microcuff Endotracheal Tube, Pediatric Oral Curved, sizes 3.0mm, 3.5mm, 4.0mm and 4.5mm, Rx...
Creator: Kimberly-Clark Corporation
Published: 2007-06-04
License: https://open.fda.gov/license/

Kimberly-Clark Corporation / initiated 2007-06-04 / Terminated

FDA source

Kimberly-Clark Corporation began a recall of Kimberly Clark Microcuff Endotracheal Tube, Pediatric Oral Curved, sizes 3.0mm, 3.5mm, 4.0mm and 4.5mm, Rx Only, Sterile, Manufacturer: Kimberly-Clark NV... on 2007-06-04. The reason FDA records is "The tubes may kink during use which may impede or prevent ventilation". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1144-2007
Status: Terminated
Initiated: 2007-06-04
Posted: 2007-08-08
Terminated: 2008-06-12
Recalling firm: Kimberly-Clark Corporation
Product: Kimberly Clark Microcuff Endotracheal Tube, Pediatric Oral Curved, sizes 3.0mm, 3.5mm, 4.0mm and 4.5mm, Rx Only, Sterile, Manufacturer: Kimberly-Clark NV Belgicastraat 13, 1930 Zaventem, Belgium, Made in Malaysia
Product code: BTR Tube, Tracheal (W/Wo Connector)
Reason for recall: The tubes may kink during use which may impede or prevent ventilation.
FDA root cause: Other
Action: Consignees were notified by letter sent via overnight mail on/about June 4, 2007. A follow-up letter was sent to consignees via fax on June 5, 2007. Consignees were instructed to cease distributing the product and return all affected product in inventory to Kimberly-Clark. Distributors were instructed to notify their accounts of the recall. A Product Recall Response Sheet (Packing Slip) was attached to the recall notice.
Quantity in commerce: 4376 cases (43760 units/total for both products)
Distribution: Worldwide, including USA, Canada, Europe, Australia, Chile, Hong Kong, Singapore, Thailand, India, Malaysia and Saudi Arabia.
Product codes and lots: Product code: 35162-07, 35162-07, 35163-07 and 35164-07, All lot numbers

Product code BTR

K050803Class IIPediatric Cuffed and Uncuffed Et Tubes; Standard Cuffed and Uncuffed Et TubesVitaid, Ltd. / cleared 2005-06-30

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)