Recall Z-1038-2012
European Custom Manufacturing B.V. · initiated April 18, 2011
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.
Codes / lots: 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.
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: Process design
Action taken
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.
Details
- Recall number
- Z-1038-2012
- Initiated
- April 18, 2011
- Posted by FDA
- February 15, 2012
- Terminated
- February 15, 2012
- Product code
- LDF – Electrode, Pacemaker, Temporary
- Quantity
- 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.
- Recalling firm
- European Custom Manufacturing B.V., Gemert