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Terminated

ATAR Reusable Extension Cable, sold under brand names: ATAR Reusable Series, ATAR 53912 Reusable Series, and XI Reusable Series. Model codes: 53912 - MDTS ATAR REUSABLE, 53912A - MDTS ATAR REUSABLE, ATAR MDTS REUSABLE, ATAR-A DARK BLUE REUSABLE, ATAR-MDT REUSABLE, ATAR-MDT2 REUSABLE, ATAR-MDT2S-A, DK BLUE 30CM REUSABLE, ATAR-MDT2S-V WHITE 30CM REUSABLE, ATAR-MDTL REUSABLE, ATAR-MDTR REUSABLE, ATAR-R REUSABLE, ATAR-R T4P REUSABLE, ATAR-R1 REUSABLE, ATAR-RL REUSABLE, ATAR-T REUSABLE, ATAR-V WHITE REUSABLE, ATAR-V2 REUSABLE, XI.A DARK BLUE REUSABLE, XI.MDT REUSABLE, XI.R REUSABLE, XI.V WHITE, REUSEABLE Cable is intended to connect an electrode/lead from a patients or another cable to a diagnostic machine or an external pacemaker

FDA Recall Z-2340-2017 · Posted 2017-04-10

Recalling FirmOscor, Inc.
Recall StatusTerminated
Product CodeIKD
Date Initiated2017-03-31
Date Terminated2024-07-15
Product Quantity19,178 units

Reason for Recall

The Reusable Oscor ATAR extension cables could separate from the connector during use.

Firm 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 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.

Root Cause

Process control

Distribution Pattern

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,

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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