U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Cable, electrode - Product Code IKD
원인
The disposable oscor atar extension cables could separate form the connector during use when the instructions for reuse are not being followed.
조치
Oscor sent an Important Information letter dated March 27, 2017, to all affected customers. The letter explained that they awee aware the Reusable Oscor ATAR extension cables could separate from the connector during use when instructions for use were not followed. They pointed out to consignees that if reused, they can only be reused a maximum of 2 times and must be resterilized by Oscor EtO.
Customers were notified again, when the recall expanded on 06/01/2017, and were sent notifications on 06/05/2017. Instructions to customers included to examine inventory, quarantine any affected devices, notify customers if further distributed, and contact Oscor to arrange for replacement.
Customers were notified a third time when the recall expanded on 06/13/2017, and notifications were sent between 06/23/2017 and 07/01/2017. Instructions included to check inventory, quarantine any affected devices, return the Acknowledgement Form, and return affected cables to Oscor.
Customers with questions should call 727-937-2511.
Worldwide Distribution -US to AL, AK, CA, CO, FL, GA, ID, IL, IN, IA , KS, KY, ME, MD, MA, MI, MN, MO, MT, NE, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WV, WI, DC. Foreign distribution to following countries: Macedonia, Pakistan, Austria, Canada, Guatemala, United Kingdom, Republic of Panama, Chile, Aruba, Saudi Arabia, Kuwait, Costa Rica, Albania, Estonia, New Zealand, Germany, Puerto Rico, Turkey, Virgin Islands, Iraq, Hong Kong, and Morocco,
제품 설명
ATAR Disposable Extension Cable, sold under brand names: ATAR Disposable Series, ATAR 53912 Disposable Series, and XI Disposable Series. || Model codes: ATAR D-A DARK BLUE DISPOSABLE, ATAR D-V WHITE DISPOSABLE, ATAR D-MDT DISPOSABLE, ATAR D-T DISPOSABLE, ATAR D-R DISPOSABLE, ATAR D-RL DISPOSABLE, ATAR D-MDTL DISPOSABLE, ATAR D-MDTS, ATAR D-R1 DISPOSABLE, ATAR D-R NP DISPOSABLE, ATAR D-MDT2, ATAR D-MDTR, ATAR D-R D2P, ATAR D-R T4P, ATAR D-R X2, ATAR D-V2, ATAR D-IS1-2PACE, PACE 101H, PACE 203H WITH ATAR D-MDTS, PACE 203H, PACE 101H WITH ATAR D-T, PACE 300, XI.D-A, DARK BLUE, DISPOSABLE, XI.D-V WHITE DISPOSABLE, XI.D-MDT DISPOSABLE 30 CM, XI.D-T DISPOSABLE, XI.D-RL, XI.D-R DISPOSABLE, 53912D - MDTS ATAR DISPOSABLE || Cable is intended to connect an electrode/lead from a patients or another cable to a diagnostic machine or an external pacemaker