Reported Jun 17, 2015 · Terminated
Edwards Lifesciences IntraClude Intra-Aortic Occlusion Device, model number ICF100, 10.5 Fr (3.5 mm) x 39.4" (100 cm)…
Edwards Lifesciences, LLC
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: Edwards Lifesciences, LLC · 12050 Lone Peak Pkwy · Draper, UT · 84020-9414
Is this the product you have?
- Edwards Lifesciences IntraClude Intra-Aortic Occlusion Device, model number ICF100, 10.5 Fr (3.5 mm) x 39.4" (100 cm) ThruPort System. Packaged sterile and non-pyrogenic in a sealed, peel-type pouch For use in patients undergoing cardiopulmonary bypass.
- Lot codes and dates
- All lots within expiration.
77 of 77 codes
594435555961394459655681597181855975195559829691599132515997380259473497596139455965568259718186597574925982969259914824599738035947879259630641596556835971818759767963598421355991482559979641594787935964448059677638597219695979031659853386599148265997964259490124596444815969584259721970597903175985338759936991599990935952356859644482596958435972197159801106598565755993699260016315595595375964962759695844597342315980110759872381599629516003103159585111596496285971818259734232
- All lots within expiration.
- Amount recalled
- 3,360 units.
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Potential device damage on the strain relief near the hub area, which may result in blood leakage.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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