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Manufacturers
RGI Medical Manufacturing, Inc.
Manufacturer Address
RGI Medical Manufacturing, Inc., 4637 NW 6th St, Gainesville FL 32609-0701
Manufacturer Parent Company (2017)
Rgi Medical Manufacturing Inc.
Source
USFDA
1 Event
Recall of Device Recall Henora
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One device in the database
Device Recall Henora
Model / Serial
Lot numbers 102131 and 110531.
Product Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
No
Distribution
US Nationwide Distribution in the states of AL, CA, DE, GA, IL, KY, MA, MD, ME, MI, MN, NJ, NM, NV, NY, OH, TN, TX, WA, and WI.
Product Description
Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set || Product Usage: || Catheter extension set for high pressure procedures.
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