Reported Jul 18, 2018 · Terminated
Coronary Sinus (CS) Uni-Directional Diagnostic Electrophysiology (EP) Catheter, catalog numbers D135303 and D135304.…
Stryker Sustainability Solutions
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: Stryker Sustainability Solutions · 1810 W Drake Dr · Tempe, AZ · 85283-4327
Is this the product you have?
- Coronary Sinus (CS) Uni-Directional Diagnostic Electrophysiology (EP) Catheter, catalog numbers D135303 and D135304
- Product UsageThe Reprocessed CS Diagnostic EP Catheter is indicated for electrophysiological mapping of cardiac structures; i.e., stimulation and recording only. The catheter is designed for use in the coronary sinus
- Lot codes and dates
2,722 of 2,722 codes
266997826699872688793268879426114272683820271572427157292715730271575727174342717435254030325403082669971267606126760622676063267606627186032718604252071025795202597159267607024550422698584269858527081502708152268353927283732728374272847127284732698582265060026715032673627267375326760522723516271937527283722667503266750426675082711911271191327140992634425266750224632662711909271845627184572727804271845427184552653972
- Amount recalled
- 2,722 units
Where it was sold
- Nationwide
Why it was recalled
Thrombogenicity test results demonstrated that both the test devices (SSS) and control devices (OM) did not meet the internal specification of non-thrombogenic .
This product could cause temporary or reversible health problems — stop using it.
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