The Recall Desk
CriticalFDA (Devices)·Z-0588-2020·Announced 2019-12-18

Cook CrossCath Support Catheter Recalled for Manufacturing Error

Cook Inc. is recalling six CrossCath Support Catheters due to a manufacturing error that may cause radiopaque marker bands to be too loose or too tight.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The FDA has classified this recall as Class I, which meets the rubric criteria for a Critical severity score.

Plain-English summary

Cook Inc. is recalling six units of the CrossCath Support Catheter, model RPN CXC3.4-2.2-18-90-P-NS-0, Order Number G51575. The recall is due to a manufacturing error that 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).

The affected devices are identified by Lot Number 9945303 and UDI (01)00827002515758(17)221308(10)9945303. These devices were distributed to facilities in the US states of AL, CA, CT, FL, GA, IL, MA, MD, MI, MO, NC, NJ, NY, OH, OK, PA, SC, TN, TX, and VA, as well as to Brazil. The devices are intended for diagnostic and interventional vascular procedures.

Healthcare providers should stop using the affected devices and contact Cook Inc. for further instructions. The FDA has classified this recall as Class I, indicating a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or death.

The recalled product

Product
CrossCath Support Catheter, RPN CXC3.4-2.2-18-90-P-NS-0, Order Number G51575 For diagnostic and interventional vascular procedures.
Manufacturer
Cook Inc.
Category
Medical Device — Vascular Catheter
Hazard
Affected units
6

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Number 9945303 UDI: (01)00827002515758(17)221308(10)9945303

Distribution

Distributed in 20 states:

Part of a larger recall action

This product is one of 4 recalled by Cook Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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