ATAR Disposable Extension Cable, sold under brand names: ATAR Disposable Series, ATAR 53912 Disposable Series, and XI Di

FDA device recall Z-2733-2017 · posted 2017-04-10 · Terminated

Recall details

Recalling firm

Oscor, Inc.

Reason for recall

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

Action taken

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

Status

Terminated

Product code

IKD

Quantity affected

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 distr

Date initiated

2017-03-31

Date posted

2017-04-10

Date terminated

2024-07-15

Location

Palm Harbor, FL

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