Recall Z-0588-2020— Cook Inc.
Class I · Terminated
Class I FDA medical device recall by Cook Inc., initiated 2019-11-08, terminated 2021-02-01. It names one FDA 510(k) clearance: K161801. Product: CrossCath Support Catheter, RPN CXC3.4-2.2-18-90-P-NS-0, Order Number G51575 For diagnostic and interventional vascular procedures.. Reason: 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)..
- Recalling firm
- Cook Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2019-11-08
- Terminated
- 2021-02-01
- Firm location
- Bloomington, IN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
CrossCath Support Catheter, RPN CXC3.4-2.2-18-90-P-NS-0, Order Number G51575 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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.