FDA Device recall Z-0589-2020
CrossCath Support Catheter, RPN CXC3.4-2.2-18-135-P-NS-0, Order Number G51583 For diagnostic and interventional vascular procedures
- FDA Device
- Class I
- terminated
- Published 2019-12-18
On 2019-12-18 the FDA classified a Class I recall of CrossCath Support Catheter, RPN CXC3.4-2.2-18-135-P-NS-0, Order Number G51583 For diagnostic and interventional vascular procedures by Cook, citing 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 cert….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0589-2020 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2019-11-08 |
| Published | 2019-12-18 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Cook |
| Distribution | AL, CA, CT, FL, GA, IL, MA, MD, MI, MO, NC, NJ, NY, OH, OK, PA, SC, TN, TX, VA |
Product
CrossCath Support Catheter, RPN CXC3.4-2.2-18-135-P-NS-0, Order Number G51583 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).
Identifiers
| code_info | Lot Numbers 9945301, 9953512 UDI: (01)00827002515833(17)221308(10)9945301 UDI: (01)00827002515833(17)221608(10)9953512 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0589-2020%22
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