Reported Feb 27, 2013 · Terminated
Maquet ELS Cannula 15 FR. Used for extracorporeal membrane oxygenation (ECMO) for the treatment of respiratory…
Maquet Cardiovascular US Sales, 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: Maquet Cardiovascular Us Sales, Llc · 45 Barbour Pond Drive · Wayne, NJ · 07470
Is this the product you have?
- Maquet ELS Cannula 15 FR. Used for extracorporeal membrane oxygenation (ECMO) for the treatment of respiratory insufficiency in infants.
- Lot codes and dates
- US Distribution Part number 701017471 Lot numbers 92046825 92065723 92076940 OUS Distribution Part Number Lot Numbers
66 of 66 codes
701002797920506167010027979205282370100279792052913701002797920581537010027979206351870100279792068260701002797920692677010027979207217770100279792075413701002797920778627010050929208186270100509292049129701005092920705547010050939204913070100509392056899701005093920655887010050939206942970100509392070553701005093920718527010050939207359870100509392076875701017471920769407010466449206358770105097892047882701050978920539307010509789205415670105097892056171701050978920568047010509789206509470105097892067382
- US Distribution Part number 701017471 Lot numbers 92046825 92065723 92076940 OUS Distribution Part Number Lot Numbers
- Amount recalled
- 41 units - US Distirbution; 216 units - OUS Distribution
Where it was sold
Why it was recalled
ELS 15 Fr Cannula could potentially contain an occluded arterial lumen.
This product could cause temporary or reversible health problems — stop using it.
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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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