The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0589-2020·Announced 2019-12-18

Cook Inc. Recalls CrossCath Support Catheters Due to Manufacturing Error

Cook Inc. is recalling 43 CrossCath Support Catheters because a manufacturing error may cause radiopaque marker bands to be too loose or too tight.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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…"

Plain-English summary

Cook Inc. is voluntarily recalling certain CXC3.0 and CXC3.4 CrossCath Support Catheters. The recall affects Order Number G51583, which includes 43 units distributed to the United States (specifically Alabama, California, Connecticut, Florida, Georgia, Illinois, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, and Virginia) and Brazil.

The recall was initiated because a manufacturing error may cause the radiopaque marker bands on these catheters to be too loose on CXC3.0 models (compatible with 0.014 wire guides) or too tight on CXC3.4 models (compatible with 0.018 wire guides). The affected lot numbers are 9945301 and 9953512.

Consumers who possess these specific catheters should stop using them and contact Cook Inc. for further instructions.

The recalled product

Product
CrossCath Support Catheter, RPN CXC3.4-2.2-18-135-P-NS-0, Order Number G51583 For diagnostic and interventional vascular procedures.
Manufacturer
Cook Inc.
Category
Medical Device — Vascular Catheter
Hazard
Affected units
43

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 Numbers 9945301

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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