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Devices
Device Recall Safe Connect
Model / Serial
Lot number: 100701
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
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.
Product Description
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).
Manufacturer
Remington Medical Inc.
1 Event
Recall of Device Recall Safe Connect
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Manufacturer
Remington Medical Inc.
Manufacturer Address
Remington Medical Inc., 6830 Meadowridge Ct., Alpharetta GA 30005
Manufacturer Parent Company (2017)
Remington Medical, Inc.
Source
USFDA
Language
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