Disposable Surgical Cable, Product Code: FL-601-97 (100), Single use, Rx Only, Remington Medical, Inc., 6830 Meadowridge Court, Alpharetta, GA 30005 Usage: Temporary pacing of open hearts: used with External Pacing Generators (EPGs).
FDA Recall Z-2223-2010 · Posted 2010-08-13
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Recalling FirmRemington Medical Inc.
Recall StatusTerminated
Product CodeDSA
Date Initiated2010-05-19
Date Terminated2010-11-29
Product Quantity1488 units
Reason for Recall
The Safe Connect component may separate from the cable, causing the cable to become unplugged from the EPG.
Firm Action
Consignees were notified on/about 05/19/2010. They were instructed to examine their inventory and quarantine product subject to the recall. If they distributed the product, they were advised to identify their customers and notify them of the recall (via the recall letter). A Return Authorization was provided. More information can be obtained by calling 770.888.8520.
Root Cause
Process design
Distribution Pattern
AZ, CA, CO, CT, DE, FL, GA, IL, IN, LA, MD, MI, MO, MS, NC, NM, NY, OH, OK, OR, PA, SC, TX, TN, TX, VA, WA, WI and Canada.
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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