Recall Z-2223-2010
Remington Medical Inc. · initiated May 19, 2010
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).
Codes / lots: Lot number: 100701
Reason for recall
The Safe Connect component may separate from the cable, causing the cable to become unplugged from the EPG.
FDA-determined 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.
Details
- Recall number
- Z-2223-2010
- Initiated
- May 19, 2010
- Posted by FDA
- August 13, 2010
- Terminated
- November 29, 2010
- Product code
- DSA – Cable, Transducer And Electrode, Patient, (Including Connector)
- Quantity
- 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.
- Recalling firm
- Remington Medical Inc., Alpharetta, GA