Microcuff Endotracheal Tube; Pediatric Oral/Nasal Magill: ID Size: 3,0mm, Microcuff Product Reference: I-MPEDC-30; ID Size: 3,5mm, Product Reference: I-MPEDC-35; ID Size: 4,0mm, Product Reference: I-MPEDC-40; ID Size: 4.5mm, Product Reference: I-MPEDC-45; ID Size: 5,0mm, Product Reference: I-MPEDC-50; ID Size: 5,5mm, Product Reference: I-MPEDC-55; ID Size: 6,0mm, Product Reference: I-MPEDC-60; ID Size: 6,5mm, Product Reference: I-MPEDC-65 and ID Size: 7,0mm, Product Reference: I-MPEDC-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.
FDA Recall Z-1263-06 · 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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.