CrossCath Support Catheter — Class I medical device recall Z-0588-2020
Terminated recall by Cook Inc., reported 2019-12-18, distributed in AL, CA, CT, FL, GA, IL, MA, MD…. A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Suppor
| Recall number | Z-0588-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cook Inc., Bloomington, IN, United States |
| Recall initiated | 2019-11-08 |
| Classified | 2019-12-09 |
| Reported by FDA | 2019-12-18 |
| Terminated | 2021-02-01 |
| Distributed | AL, CA, CT, FL, GA, IL, MA, MD, MI, MO, NC, NJ, NY, OH, OK, PA, SC, TN, TX, VA |
| Countries outside the US | BR |
| Quantity | 6 |
| UPC / GTIN / UDI-DI | 00827002515758 |
| Lot numbers | 9945303 |
Product
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0588-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.