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.
FDA Recall Z-1265-06 · Posted 2006-07-25
Recalling FirmMicrocuff Gmbh
Recall StatusTerminated
Product CodeBTR
Date Initiated2006-06-19
Date Terminated2007-05-01
Product Quantity1730 units (total for all three types)
Reason for Recall
Inadequate seals and/or holes in the pouch may compromise the sterility of the product.
Firm Action
A notification by telephone was made in April 2006. A confirmation letter was later sent on 6/29/2006.
Root Cause
Other
Distribution Pattern
U.S.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.