Z-0578-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 4, 2019
- Initiation Date
- October 24, 2019
- Termination Date
- March 20, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14,145 devices total
Product Description
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.
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 Pattern
Nationwide including Washington D.C. and Puerto Rico. OUS to include Canada.
Code Information
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.