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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 Microcuffsee related information
Date Initiated by FirmJune 19, 2006
Date PostedJuly 25, 2006
Recall Status1 Terminated 3 on May 01, 2007
Recall NumberZ-1263-06
Recall Event ID 35753
510(K)NumberK050803 
Product Classification Endotracheal Tube Pediatric Oral/Nasal Magill - Product Code BTR
ProductMicrocuff 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.
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 ContactMr. 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
ActionA notification by telephone was made in April 2006. A confirmation letter was later sent on 6/29/2006.
Quantity in Commerce1730 units (total for all three types)
DistributionU.S.
Total Product Life CycleTPLC 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.
510(K) Database510(K)s with Product Code = BTR
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