Home / Recalls / Ra Medical Systems, Inc. / Z-2006-2020

Z-2006-2020 Class II Terminated

Recalled by Ra Medical Systems, Inc. — Carlsbad, CA

Recall Details

Product Type
Devices
Report Date
May 20, 2020
Initiation Date
September 19, 2019
Termination Date
July 31, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5082 products

Product Description

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

Reason for Recall

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.

Distribution Pattern

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

Code Information

DABRA 101 Catheter. Ref: 1222-5000-01 Serial Number(s): Manufacturing dates 2018-09-03 to 2019-08-26. Expiration dates: September 2019 to August 2020

Other recalls by Ra Medical Systems, Inc.

  • Z-0569-2021 Class II — DABRA Laser (RA-308 Excimer Laser) Intended Use: For use in ablating a channe (October 16, 2020)
  • Z-0050-2021 Class II — DABRA RA-308 Excimer Laser, SN: ******* - Product Usage: The device is intended (July 24, 2020)
  • Z-2497-2020 Class II — DABRA Laser (RA-308 Excimer Laser). The DABRA Laser and DABRA Catheter is an exc (January 23, 2020)
  • Z-1631-2020 Class II — Pharos Excimer Laser, Model: EX-308 - Product Usage: The Pharos EX-308 Excimer L (August 23, 2019)
  • Z-2218-2019 Class II — The DABRA Laser (model RA-308) is designed to provide ultraviolet laser energy e (February 15, 2018)
  • Z-2123-2014 Class II — PHAROS Excimer Laser, Model No. EX-308 UVB phototherapy for the treatment of (June 30, 2014)