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U.S. Department of Health and Human Services

Class 2 Device Recall Microcuff

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  Class 2 Device Recall Microcuff see related information
Date Initiated by Firm June 19, 2006
Date Posted July 25, 2006
Recall Status1 Terminated 3 on May 01, 2007
Recall Number Z-1264-06
Recall Event ID 35753
Product Classification Pediatric Endotracheal Tubes - Oral Pre-Curved - Product Code BTR
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.
Code Information All lots of the product manufactured are being recalled
Recalling Firm/
Manufacturer		 Microcuff Gmbh
Honer Weg 2 4
Weinheim Germany
For Additional Information Contact Mr. Mark Bussone
770-587-8393
Manufacturer Reason
for Recall		 Inadequate seals and/or holes in the pouch may compromise the sterility of the product.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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