Contamination Resulted To Recall Of Medical Devices In Many Companies. Cook Medical Guidewires has issued a voluntary recall affecting 8,750 units of its Roadrunner UniGlide Hydrophilic Wire Guides because the coating may contain glass particulates.
DSM Biomedical B.V., who supplies the coating and launched a recall of its own, notified Cook of the issue. The sizes of the glass particles range from 4 to 280 microns. Roadrunner UniGlide Hydrophilic Wire Guides are used to help place percutaneous catheters into peripheral vasculature.
Cook asked affected customers to quarantine the recalled guidewires and stop using them. The company requests that the products be returned for credit as soon as possible. Using the recalled products may lead to bleeding, blood vessel damage and blood clots in the circulatory system, according to an Aug. 15 recall notice.
Launching of Recalls Began
Cook launched the recall on June 24, 2016. No injuries have been reported so far. The company received one lot of guidewires affected by the issue, the recall alert said.
The company said the recall was a “precautionary measure, because it cannot exclude the possibility that glass particles passed through during processing and could be present in the coating of the recalled wire guide units.”
This recall is the latest setback for Cook, who expanded on a recall to include 4.1 million catheters with Beacon Tip technology in April. The products were recalled due to reports of the tips splitting or fracturing during procedures. This action expanded on a smaller recall in 2015 affecting 95,167 units.
In February, Cook recalled 360 lots, 17,827 units worldwide, of its single lumen central venous catheters and pressure monitoring sets and trays due to the risk of catheter tip fracture and/or separation.