Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Microcuff

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  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-1265-06
Recall Event ID 35753
Product Classification Adult Endotracheal Tubes - Oral/Nasal Magill with Murphy Eye - Product Code BTR
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.
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.
-
-