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).
This recall has been terminated (originally issued August 13, 2010).
- Company
- Remington Medical Inc.
- Recall Initiated
- May 19, 2010
- Posted
- August 13, 2010
- Terminated
- November 29, 2010
- Recall Number
- Z-2223-2010
- Quantity
- 1488 units
- Firm Location
- Alpharetta, GA
- Official Source
- View on FDA website ↗
Reason for Recall
The Safe Connect component may separate from the cable, causing the cable to become unplugged from the EPG.
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.
Lot / Code Info
Lot number: 100701
Root Cause
Process design
Action Taken
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.
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