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U.S. Department of Health and Human Services

Class 2 Device Recall Safe Connect

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 Class 2 Device Recall Safe Connectsee related information
Date Initiated by FirmMay 19, 2010
Date PostedAugust 13, 2010
Recall Status1 Terminated 3 on November 29, 2010
Recall NumberZ-2223-2010
Recall Event ID 55804
510(K)NumberK971968 
Product Classification Cable, transducer and electrode, patient (including connector) - Product Code DSA
ProductDisposable 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
FEI Number 1000132370
Recalling Firm/
Manufacturer		 Remington Medical Inc.
6830 Meadowridge Ct.
Alpharetta GA 30005
For Additional Information ContactLynne Buchanan-Kopp
770-888-8520
Manufacturer Reason
for Recall		The Safe Connect component may separate from the cable, causing the cable to become unplugged from the EPG.
FDA Determined
Cause 2		Process design
ActionConsignees 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 Commerce1488 units
DistributionAZ, 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 CycleTPLC Device Report
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.
510(K) Database510(K)s with Product Code = DSA
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