Cook Medical has launched a voluntary recall of nearly 59,000 devices intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
The Flexor Check-Flo introducer and Flexor Tuohy-Borst side-arm introducer (Shuttle Select) are sterile, single-use devices that incorporate a hydrophilic-coated shaft in varying stiffnesses with distal radiopaque markers. The recall covers specific lots of 4-9 Fr Flexor Check-Flo Introducers (high-flex Ansel) and 5 & 6 Fr Flexor Shuttle Select introducers, totaling 58,499 units globally, according to the recall notice.
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