Reported May 20, 2020 · Terminated
Ra Medical Systems DABRA Catheter 5F (1.5mm), REF: 1222-5000-01, LOT: 18-090400-094, USE BY: 2019-09-24, MFR DATE:…
Ra Medical Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ra Medical Systems, Inc. · 2070 Las Palmas Dr · Carlsbad, CA · 92011-1518
Is this the product you have?
6 of 6 products
| Model / number | Barcodes | Product as published |
|---|---|---|
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) | |
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 | |
1222-5000-01 | — | |
| — | 008423621000312019092400041 | Lot: LOT: 19-092400-041, USE BY: 2019-12-13, UDI's (01)00842362100031, (17)20191213(21)2019092400041 |
- Lot codes and dates
- DABRA 101 Catheter
- Ref1222-5000-01
- Serial Number(s)Manufacturing dates 2018-09-03 to 2019-08-26
- Expiration datesSeptember 2019 to August 2020
- Amount recalled
- 5082 products
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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