Device product
CrossCath Support Catheter, RPN CXC3.4-2.2-18-150-P-NS-0, Order Number G51577 For diagnostic and interventional vascular procedures.
Z-0590-2020
Product summary
- Firm
- Cook Inc.
- Event
- Event 84212
- Status
- Terminated
- Classification
- Class I
- Quantity
- 58
- Official record key
device-enforcement:Z-0590-2020
Official wording
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).
Code information: Lot Numbers 9950878, 9953506 UDI: (01)00827002515772(17)221508(10)9950878 UDI: (01)00827002515772(17)221608(10)9953506
Distribution pattern: 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.
Derived failure modes
-
Manufacturing or process control
manufacturing error