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Terminated

Maquet ELS Cannula 15 FR. Used for extracorporeal membrane oxygenation (ECMO) for the treatment of respiratory insufficiency in infants.

FDA Recall Z-0839-2013 · Posted 2013-02-20

Recalling FirmMaquet Cardiovascular Us Sales, Llc
Recall StatusTerminated
Product CodeDWF
Date Initiated2012-12-26
Date Terminated2014-05-08
Product Quantity41 units - US Distirbution; 216 units - OUS Distribution

Reason for Recall

ELS 15 Fr Cannula could potentially contain an occluded arterial lumen.

Firm Action

Maquet sent Urgent Device Recall Letters/Recall Acknowledgement Forms to their customers on 12/26/2012.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution-USA including the states of AZ, CO, FL, TN, and TX and the countries of Australia, Canada, Czech Republic, Dubai/Bahrain/Kuwait/Lebanon/Saudi Arabia/Yemen, France, Germany, Hong Kong, Italy, Japan, Netherlands, Singapore, South Africa, Sweden, Switzerland, Thailand, Turkey, and UK.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K002857ELS CANNULA (KIT), MODEL M1210-88,M1510-88Jostra AG · 2000-10-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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