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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85344

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
September 19, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Ra Medical Systems, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-2006-2020
Recall number
Z-2006-2020
Initiated
September 19, 2019
Classification
Class II
Status
Terminated
Recalling firm
Ra Medical Systems, Inc.
Quantity
5082 products

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

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

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