Guidezilla II Guide Extension Catheter Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7493933515060, 6F; 2. REF/Catalog No H7493933515070, 7F.
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation is recalling certain Guidezilla II Guide Extension Catheters in 6F size that were sterilized using ethylene oxide. The catheters may have missed the hydrophilic coating step during manufacturing, which is responsible for creating a lubricious (slippery) surface on the devices. A total of 14,145 devices have been distributed nationwide, including Washington D.C. and Puerto Rico, as well as to Canada.
The affected devices are identified by specific lot numbers and catalog numbers, with use-by dates ranging from September 2019 through June 2021. The recall document does not specify a remedy or instructions for what affected consumers should do.
Written by software from the official notice below. Not reviewed by a lawyer.
Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices, during the manufacturing process.
Reason for recall: Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices, during the manufacturing process. Distribution: Nationwide including Washington D.C. and Puerto Rico. OUS to include Canada. Quantity: 14,145 devices total Lot/code info: Lot / GTIN Number / Use By: 1. 23485544 / 8714729939450 / 2021-02-10, 23933296 / 8714729939450 /2021-05-10, 23947883 / 8714729939450 / 2021-05-12, 24137846 / 8714729939450 / 2021-06-17. 2. Lots: 21305995 / 8714729939474 / 2019-09-25, 24201181 / 8714729939474 / 2021-06-30.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.