Cook—Advance 35LP Low-Profile PTA Balloon Dilatation Catheters: Packaging May Be Mislabeled
May 2, 2018 | Risk Management News
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In an April 16, 2018, Urgent Medical Device Recall letter submitted by an ECRI Institute member hospital, Cook states that the above catheters may have been inadvertently switched during the packaging process. The product packaging labeled as a 6 mm x 2 cm balloon may contain a 4 mm x 4 cm balloon, and vice versa, potentially leading to a delay in procedure caused by the need for balloon catheter replacement. If a larger balloon size is inadvertently used in...