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.
Reported: December 4, 2019 Initiated: October 24, 2019 #Z-0578-2020
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.
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- 14,145 devices total
- Distribution
- Nationwide including Washington D.C. and Puerto Rico. OUS to include Canada.
- Location
- Maple Grove, MN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Boston Scientific Corporation. Units affected: 14,145 devices total.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 4, 2019. Severity: Moderate. Recall number: Z-0578-2020.
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