The Halo One Thin-Walled Guiding Sheath.
January 31, 2017 — Bard Peripheral Vascular Inc. is recalling the Halo One Thin-Walled Guiding Sheath because the sheath body may separate from the sheath hub while removing the device from the patient's leg. The company also reports that the sheath may kink, and that its tip may become damaged during the procedure. The U.S, Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall.
Bard said the use of affected sheaths may result in prolonged procedure times and on additional surgical intervention to remove detached components from the patient. The affected product may cause other serious adverse health consequences such as internal tears and perforation to arteries or veins, excessive bleeding and death. The Halo One Thin-Walled Guiding Sheath is used to introduce and/or guide the placement of interventional and diagnostic devices into veins and arteries through an incision made on a patient's leg.
On Jan. 10, 2017, Bard sent a medical device recall notification, which instructed consignees to stop using, or further distributing, any affected products. It also requested checks all inventory locations for affected product codes and lot numbers and to remove any affected products from the shelves.
If an affected product has been used, Bard asked users to complete and return the "Recall and Effectiveness Check Form," which was attached to the notification, and which indicates no product will be returned.
The effected lots of the Halo One Thin-Walled Guiding Sheath involved in the recall include product codes HAL545, HAL590 and HAL510F. Lot numbers include: 50137556, 50137557, 50137598 50137682 50137723, 50137735, 50137875, 50137965, 50138274, 50138119, 50138118, 50138122, 50138273, 50138435, 50138437, 50138701, 50138439, 50137570, 50137770, 50137979, 50138696, 50137866, 50137924, 50138170 and 50138765. The manufacturing dates include product made between April 12, 2016 to July 7, 2016. Distribution dates include: June 24, 2016 to July 12, 2016.
The recall included 101 units distributed in Arizona, Florida, Kansas, Louisiana, Maine, Michigan, Missouri, Nevada, New Hampshire, New York, Ohio, Texas, Utah, and Washington.
For more information, contact the firm's recall coordinator at (800) 321-4254, Option #2, Ext. 2501 (Monday - Friday 6 a.m. to 3 p.m. Mountain Standard Time), or by e-mail at [email protected]
For more information from the FDA: www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm538821.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery