FDA-Device2019-12-04Class II
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.
Boston Scientific Corporation
Hazard
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.
Sold states
Nationwide including Washington D.C. and Puerto Rico. OUS to include Canada.
Affected count
14,145 devices total
Manufactured in
1 Scimed Pl, Maple Grove, MN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0578-2020Don't want to check this manually?
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