Cook Medical Recalls Wire Guides Due to Potential Glass in Hydrophilic Coating

By MedTech Intelligence Staff
September 6, 2016


• Categories: 03-Manufacturing Execution, 05-Quality/Regulatory, RC - Medical Device Audits, Certification & Verification

Recalls and other field actions are an unavoidable part of the medical device industry. Join MedTech Intelligence for MEDICAL DEVICE RECALLS: Procedures & Best Practices | November 14–15 in Boston, MA | December 5–6 in Schaumburg, ILCook Medical has recalled 8750 wire guides in the United States due to potential glass particle contamination. The Class I recall, the most serious type of medical device recall, of the Roadrunner Uniglide Hydrophilic Wire Guide was issued after Cook Medical’s supplier of the hydrophilic coating recalled lots of the material. According to an FDA update, Cook Medical received one lot of the recalled coating.

“Cook is taking this action as a precautionary measure, because it cannot guarantee that there are no glass particles in the coating of the recalled wire guide units,” according to an FDA alert. “Potential adverse events that may occur as a result of this contamination could include vessel damage, bleeding and embolic particulate in the circulatory system.”

The devices, which are used by physicians to insert a catheter through the skin and into the peripheral vascular system, were distributed between May 2 and June 17 this year. Cook Medical has posted the affected lot numbers on its website.