FDA recall Z-0578-2020

Product

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

Nationwide including Washington D.C. and Puerto Rico. OUS to include Canada.

Key facts

Status

Terminated

Initiation date

2019-10-24

Report date

2019-12-04

Termination date

2023-03-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Maple Grove, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0578-2020