FDAFDA · Food and drugs·Recall number Z-0590-2020
CrossCath Support Catheter, RPN CXC3.4-2.2-18-150-P-NS-0, Order Number G51577 For diagnostic and interventional vascular procedures.
Published December 18, 2019 · Recall initiated: November 8, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Cook Inc.
- Distributor
- 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.
- Lot
- Lot Numbers 9950878, 9953506 UDI: (01)00827002515772(17)221508(10)9950878 UDI: (01)00827002515772(17)221608(10)9953506
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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