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Ra Medical Systems, Inc. recalls Ra Medical Systems DABRA Catheter 5F (1.5mm), REF: 1222-5000-01, LOT: 18-090400-094, USE BY: 2019-09-24, MFR DATE: 2018-
Recalled May 20, 2020 · FDA recall Z-2006-2020 · Ra Medical Systems
Hazard
The firm has become aware there is a potential problem with its DABRA catheters resulting in higher catheter calibration failure rate due to the product shelf life is currently less than the labeled shelf life. · FDA Class II
Units
5082 products
Sold at
Worldwide Distribution - US Nationwide - MI, TN, CA, FL, OR, PA, AZ, AL, VA, GA, TX, ID, AR, NC, IN, SC, CT, NY, KS, LA, NV, MS, NE, MD, IL, OK, MA, WA, MO, WI, KY. OUS - Netherlands, Pakistan, United Kingdom, Italy, France
Description
The firm has become aware there is a potential problem with its DABRA catheters resulting in higher catheter calibration failure rate due to the product shelf life is currently less than the labeled shelf life.
Product
Ra Medical Systems DABRA Catheter 5F (1.5mm), REF: 1222-5000-01, LOT: 18-090400-094, USE BY: 2019-09-24, MFR DATE: 2018-09-24, CE, Laser Radiation, STERILE (Gamma Sterilized), Single Use Only Revised Label: Product Label - Ra Medical Systems DABRA Catheter 5F (1.5mm), REF: 1222-5000-01, LOT: 19-092400-041, USE BY: 2019-12-13, MFR DATE: 2019-10-14, CE 2797, Laser Radiation, STERILE (Gamma Sterilized), Single Use Only Package Label - DABRA 101 5 French, Ref: 1222-5000-01, Lot: LOT: 19-092400-041, USE BY: 2019-12-13, UDI's (01)00842362100031, (17)20191213(21)2019092400041
Manufacturer(s)
Ra Medical Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →