FDA has designated the previously announced recall as Class I.

Qmed Staff

FDA on Tuesday announced a Class I designation for a previously announced Cook Medical recall of thousands of guidewires with coating that is potentially contaminated with glass particles. 

FDA listed 8750 units of the Roadrunner UniGlide Hydrophilic Wire Guide involved in the recall. The guidewires were distributed between May 2 and June 17 of this year. 

Cook had already announced the recall, but the Class I designation drums home just how serious it actually was. The problem appears to have originated at the coatings supplier, Dutch company DSM Biomedical B.V. 

DSM alerted Cook to the possible glass contamination in the coating, issuing its own recall in the process, according to a statement from Cook.

Cook has described its recall as a precautionary method. The coating is meant to help in tracking and pushing of the guidewires, which aid the delivery of percutaneous catheters to the peripheral vasculature. The potential glass particles, ranging from about 4 microns to 280 microns in size, could potentially cause vessel damage, bleeding, and the presence of blood clot particles in the circulatory system.

Cook has asked hospitals and healthcare providers to quarantine affected products, and return them to Stericycle Expert Solutions (a third-party recall administration service provider). 

The recall comes months after the Bloomington, IN-based medical device company announced it was voluntarily recalling about 4.1 million of its catheters with Beacon Tip technology because of complaints of the tips splitting or fracturing during procedures. The April recall expanded on a much smaller 2015 recall that involved 95,167 devices. Cook officials decided to recall all lots and sizes of the catheters to "assure patient safety."

Cook suffered another major catheter recall in February. The February recall involved 360 lots, or 17,827 devices globally, of single lumen central venous catheters and pressure monitoring sets and trays. 

Chris Newmarker is senior editor of Qmed. Follow him on Twitter at @newmarker.

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