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Class 2 Device Recall Safe Connect |
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Date Initiated by Firm |
May 19, 2010 |
Date Posted |
August 13, 2010 |
Recall Status1 |
Terminated 3 on November 29, 2010 |
Recall Number |
Z-2223-2010 |
Recall Event ID |
55804 |
510(K)Number |
K971968
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Product Classification |
Cable, transducer and electrode, patient (including connector) - Product Code DSA
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Product |
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). |
Code Information |
Lot number: 100701 |
Recalling Firm/ Manufacturer |
Remington Medical Inc. 6830 Meadowridge Ct. Alpharetta GA 30005
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For Additional Information Contact |
Lynne Buchanan-Kopp 770-888-8520
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Manufacturer Reason for Recall |
The Safe Connect component may separate from the cable, causing the cable to become unplugged from the EPG.
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FDA Determined Cause 2 |
Process design |
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. |
Quantity in Commerce |
1488 units |
Distribution |
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. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = DSA and Original Applicant = REMINGTON MEDICAL, INC.
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