CrossCath Support Catheter, RPN CXC3.4-2.2-18-135-P-NS-0, Order Number G51583 For diagnostic and interventional vascular procedures.
Reported: December 18, 2019 Initiated: November 8, 2019 #Z-0589-2020
Product Description
CrossCath Support Catheter, RPN CXC3.4-2.2-18-135-P-NS-0, Order Number G51583 For diagnostic and interventional vascular procedures.
Reason for Recall
A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) and too tight on certain CXC3.4 CrossCath Support Catheters (compatible with 0.018 wire guides).
Details
- Recalling Firm
- Cook Inc.
- Units Affected
- 43
- Distribution
- Distribution to US states of AL, CA, CT, FL, GA, IL, MA, MD, MI, MO, NC, NJ, NY, OH, OK, PA, SC, TN, TX, and VA, and Brazil.
- Location
- Bloomington, IN
Frequently Asked Questions
What product was recalled? ▼
CrossCath Support Catheter, RPN CXC3.4-2.2-18-135-P-NS-0, Order Number G51583 For diagnostic and interventional vascular procedures.. Recalled by Cook Inc.. Units affected: 43.
Why was this product recalled? ▼
A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) and too tight on certain CXC3.4 CrossCath Support Catheters (compatible with 0.018 wire guides).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 18, 2019. Severity: Critical. Recall number: Z-0589-2020.
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