Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1265-06

Microcuff Adult Endotracheal Tubes - Oral/Nasal Magill with Murphy Eye * ID Size: 5,0mm, Microcuff Product...

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

Microcuff Gmbh began a recall of Microcuff Adult Endotracheal Tubes - Oral/Nasal Magill with Murphy Eye * ID Size: 5,0mm, Microcuff Product Reference: I-HMICU-50; ID Size: 5.5mm, Product... on . The reason FDA records is "Inadequate seals and/or holes in the pouch may compromise the sterility of the product". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number
Z-1265-06
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Microcuff GmbH
Product
Microcuff Adult Endotracheal Tubes - Oral/Nasal Magill with Murphy Eye * ID Size: 5,0mm, Microcuff Product Reference: I-HMICU-50; ID Size: 5.5mm, Product Reference: I-HMICU- 55; ID Size: 6.0mm, Product Reference: I-HMICU- 60; ID Size: 6.5mm, Product Reference: I-HMICU- 65; ID Size: 7.0mm, Product Reference: I-HMICU- 70; ID Size: 7.5mm, Product Reference: I-HMICU-75; ID Size: 8.0mm, Product Reference: I-HMICU-80; ID Size: 8.5mm, Product Reference: I-HMICU-85; ID Size: 9.0mm, Product Reference: I-HMICU-90; and ID Size: 10.0mm Product Reference: I-HMICU-10 * 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.