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U.S. Department of Health and Human Services

Class 2 Device Recall Temporary Pacing Wire

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  Class 2 Device Recall Temporary Pacing Wire see related information
Date Initiated by Firm April 18, 2011
Date Posted February 15, 2012
Recall Status1 Terminated 3 on February 15, 2012
Recall Number Z-1038-2012
Recall Event ID 60942
510(K)Number K033858  
Product Classification Electrode, pacemaker, temporary - Product Code LDF
Product Temporary Pacing Wire, BIPOLAR, Models BM, V, VE and VF, Rx Only, STERILE/EO, Single use only -- Mce (MEDICAL CONCEPTS EUROPE) --- Manufacturer ECM B.V. Oost-Om 54, P.O. Box 53, NL 5420 AB GEMERT --- Shipping or Unit Package: 20 individual units packaged per box with 6 boxes per case. --- Device Classification Name: Electrode, pacemaker, temporary. ---The device is supplied sterile and intended for single use.

Used to pace the heart during or after open heart surgery. The electrodes are placed on the heart; the other end of the pacing wire is inserted through the skin of the patient with a thoracic needle. The thoracic needle can snap-off at the end where the pacing wire is attached, after snap-off the remaining pins are connected to an external pacemaker. For temporary atrial and ventrical pacing and sensing for contemplated implant duration of 7 days or less.
Code Information Model BM Lot numbers 1101044-10, 1012035-10, 1012036-10, 1011128-10, 1101023-10, 1101134-10, 1102035-10, 1102061-10, 1009089-10; -- Model V lot number: 1103066-10; -- Model VE lot numbers: 1101055-10, 1101008-10;  -- Model VF lot numbers: 1011092-10, 1011148-20, 1012038-10, 1101021-10, 1101136-10.
Recalling Firm/
Manufacturer		 European Custom Manufacturing B.V.
Oost-Om 54
Gemert Netherlands
For Additional Information Contact Mr. R. Bertolero
925-487-9429
Manufacturer Reason
for Recall		 The crimping operation during product production was not performed properly. As such, the pacing wire may separate from the connection pin, which causes non-functionality.
FDA Determined
Cause 2		 Process design
Action ECM sent an "ECMbv RECALL OF MCE TEMPORARY PACING WIRES" letter dated May 2, 2011 to all affected customers. Customers were also informed of a potential problem via e-mail and/or phone between April 18 and 21, 2011. The letter describes the product, problem, and actions to be taken by the customers. Customers were instructed to place the affected product on hold and to return the product to the firm. For questions on this matter, contact ECM or MCE Customer Service at 1-877-886-1985.
Quantity in Commerce 2,120 individual units (106 boxes)
Distribution Nationwide Distribution-including the states of AL, AR, CA, FL, GA, KY, NC, NV, NY, TX, VA, and WI.
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.
510(K) Database 510(K)s with Product Code = LDF and Original Applicant = EUROPEAN CUSTOM MANUFACTURING BV
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