Recall Z-2733-2017 ยท IKD Cable, Electrode
Oscor, Inc.
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
| Date | Apr 10, 2017 (initiated Mar 31, 2017) |
| Status | Terminated |
| Reason | The Reusable Oscor ATAR extension cables could separate from the connector during use. |
| Root cause | Process control |
| Action | 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 dev |
| Quantity | 36,242 units |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070926 | ELECTRODE/EXTENSION CABLES, MODELS ATAR Oscor, Inc., Jun 7, 2007 |