Z-1264-06

Microcuff Pediatric Endotracheal Tubes - Oral Pre-Curved: ID Size: 3,0mm, Microcuff Product Reference...

Name: Z-1264-06 Microcuff Pediatric Endotracheal Tubes - Oral Pre-Curved: ID Size: 3,0mm, Microcuff Product Reference...
Creator: Microcuff Gmbh
Published: 2006-06-19
License: https://open.fda.gov/license/

Microcuff GmbH / initiated 2006-06-19 / Terminated / root cause: packaging

FDA source

Microcuff Gmbh began a recall of Microcuff Pediatric Endotracheal Tubes - Oral Pre-Curved: ID Size: 3,0mm, Microcuff Product Reference: I-MPEDC-30; ID Size: 3,5mm, Product Reference... on 2006-06-19. The reason FDA records is "Inadequate seals and/or holes in the pouch may compromise the sterility of the product". 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-1264-06
Status: Terminated
Initiated: 2006-06-19
Posted: 2006-07-25
Terminated: 2007-05-01
Recalling firm: Microcuff GmbH
Product: Microcuff Pediatric Endotracheal Tubes - Oral Pre-Curved: ID Size: 3,0mm, Microcuff Product Reference: I-MPEDC-30; ID Size: 3,5mm, Product Reference: I-MPEOC-35; ID Size: 4,0mm, Product Reference: I-MPEOC-40; ID Size: 4.5mm, Product Reference: I-MPEOC-45; ID Size: 5,0mm, Product Reference: I-MPEOC-50; ID Size: 5,5mm, Product Reference: I-MPEOC-55; ID Size: 6,0mm, Product Reference: I-MPEOC-60; ID Size: 6,5mm, Product Reference: I-MPEOC-65 and ID Size: 7,0mm, Product Reference: I-MPEOC-70 * Sterile * Single use only * Manufactured by Euromedical Industries, Sdn. Bhd., Bakar Arang Industrial Estate, 08000 Sungai Patani, Kedah, Malaysia * Distributed by: Microcuff GmbH, Hohnerweg 2-4, D-69469 Weinheim, Germany.
Product code: BTR Tube, Tracheal (W/Wo Connector)
Reason for recall: Inadequate seals and/or holes in the pouch may compromise the sterility of the product.
Root cause tag: packaging
FDA root cause: Other
Action: A notification by telephone was made in April 2006. A confirmation letter was later sent on 6/29/2006.
Quantity in commerce: 1730 units (total for all three types)
Distribution: U.S.
Product codes and lots: All lots of the product manufactured are being recalled

Product code BTR

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)