Ra Medical Systems recalls DABRA Catheter 5F (1.5mm) models with potential calibration failures due to shelf life exceeding labeled expiration. Affected units have specific lot numbers and use-by dates.
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.
Ra Medical Systems is recalling DABRA Catheter 5F (1.5mm) models that may have calibration failures because the product's actual shelf life is shorter than the labeled expiration date. This could lead to improper medical device calibration if used after the expiration date.
The catheter's calibration may fail if used after the expiration date because the product's actual shelf life is shorter than the labeled expiration. This could lead to improper medical device calibration during procedures.
Healthcare professionals using the DABRA Catheter 5F (1.5mm) for medical procedures are most at risk if they use units beyond the labeled expiration date. Patients receiving these catheters may face calibration issues if the device fails.
Check for the model DABRA Catheter 5F (1.5mm) with reference number 1222-5000-01. Look for lot numbers starting with 18-090400-094 or 19-092400-041 and use-by dates up to September 2019.
Look for the reference number 1222-5000-01 and lot numbers starting with 18-090400-094 or 19-092400-041 on the catheter packaging.
The recall is due to a potential calibration failure risk because the product's actual shelf life is shorter than the labeled expiration date.
The official recall notice does not specify a remedy or action for affected units.
Check for the reference number 1222-5000-01 and lot numbers starting with 18-090400-094 or 19-092400-041 on the packaging.
We’ve drafted a message you can send Ra Medical Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-2006-2020 — Ra Medical Systems Ra Medical Systems Hello, I own a Ra Medical Systems that is covered by recall Z-2006-2020 from Ra Medical Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
