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General Product Information


Find Basic Information for All Cook Products

Availability

We make every effort to keep all of our catalog items in stock. We have 16,000 products, though, so we can’t guarantee that all of them will be in stock. If you have any questions about the availability of a certain product, just contact us.

Warranty

We warrant that our products were true to label when we manufactured them, and that we prepared and tested them according to the quality system regulations of the appropriate regulatory bodies.

Because of biological differences between people, no product is 100% effective in all circumstances. We can’t control the diagnosis of the patient, or the method of use, storage condition, and handling of the product after it leaves our possession. As a result, we don’t warrant either a good effect or against an ill effect from the use of the product.

This warranty is exclusive and in place of all other written, oral, or implied warranties (including any warranties of merchantability or fitness for purpose). The buyer accepts the product, subject to all terms of this warranty. No representative of the company can change any of the previously mentioned terms.

Design Changes

Cook reserves the right to change or discontinue any product without notice. If a product is discontinued, we can recommend alternatives.

Expiration

Most Cook products have an expiration date on the label to ensure product integrity and sterility. We can’t verify an unlimited shelf life through testing, so we usually put some limit on the life of our products. Please be aware that storage conditions may affect shelf life.

Storage

Cook products should be stored in a dark, cool, dry place. Light can degrade some plastics, so don’t expose products to light for extended periods. Heat can reduce the shelf life of products, so don’t expose products to elevated temperatures for extended periods.

Sterilization

We use an environmentally friendly mixture of ethylene oxide (EtO) as a sterilant. EtO is compatible with a wide variety of manufacturing materials and with sealed Tyvek® packaging.

Tyvek is an excellent microbial barrier that maintains sterility throughout a product’s shelf life if the following conditions are met:

  • The package seal remains intact
  • The package is not exposed to hostile environmental storage conditions such as the following:
  • Temperatures above 104 ºF (40 ºC)
  • Relative humidity above 90%
  • Condensing humidity

Most institutions can’t duplicate the sterilization parameters that we use, so we provide tested sterilization cycles, based on AAMI-recommended practices, that institutions can use to achieve a sterility assurance level of 10-6.

If a copy of the AAMI’s Standards and Recommended Practices for sterilization isn’t available at your institution, you can contact the AAMI at 703.525.4890 or 800.332.2264 ext. 217.

Sterilizing Products with Ethylene Oxide (EtO)

To use EtO to sterilize a reusable product or an unused disposable product, you must first properly clean and disinfect the product. Then you must package the product according to the recommendations of the Association for the Advancement of Medical Instrumentation (AAMI). Refer to the product’s instructions for use or contact Customer Service for specific information about proper sterilization methods.

If a product must be coiled to fit into the sterilization chamber, the coil must be at least 8 inches in diameter. Don’t load more than 11 products per cubic foot of chamber space into the EtO sterilization chamber. Don’t exceed the usable chamber space. If a product is damaged, take it out of service immediately.

You can sterilize a nonsterile product one time if it is unused. You can also sterilize an unused product one time if it was sold sterile but was accidentally opened. Some products must not be sterilized with EtO. The institution that operates the sterilization equipment is responsible for validating the equipment.

Table 1 shows the recommended EtO sterilization cycle parameters:

Table 1 – EtO Sterilization Cycle Parameters

Parameter Set Point
Pre-vacuum pressure 2.0 psia (-25.9 inch Hg vac)
Relative humidity 60% RH
Humidity dwell 20 minutes
Chamber temperature 54.4 ºC (130 ºF)
Exposure pressure To be determined (1)
Exposure dwell time 2 hours
EtO concentration 600 mg/L
Post-vacuums 3
EtO concentration 600 mg/L
Post-vacuum pressure 2.0 psia (-25.9 inch Hg vac)
Air wash (2) 5 minutes
Aeration temperature 54.4 ºC (130 ºF)
Air changes during aeration 90 per hour

Sterilizing Products in an Autoclave

To sterilize a reusable product or an unused disposable product in an autoclave, you must first properly clean and disinfect the product. Then you must package the product by using the practices recommended by the Association for the Advancement of Medical Instrumentation (AAMI). Refer to the product’s instructions for use or contact Customer Service for specific information about proper sterilization methods.

If a product must be coiled to fit into the chamber, the coil must be at least 8 inches in diameter. Don’t put the original product packaging through an autoclave cycle—the packaging won’t withstand the sterilization temperature. Some products must not be autoclaved.

Don’t load more than 10 products per cubic foot of chamber space into the autoclave loader. Don’t exceed the usable chamber space. If a product is damaged, take it out of service immediately. The institution that operates the sterilization equipment is responsible for validating the equipment.

Table 2 shows the recommended autoclave sterilization cycle parameters:

Table 2 – Autoclave Sterilization Cycle Parameters

Parameter Set Point
Cycle type Pre-vacuum
Pre-vacuum pressure 2.5 psia (-24.8 inch Hg vac)
Chamber exposure temperature 132.2 ºC (270 °F)
Chamber exposure pressure 41.8 psia (27.1 psig)
Exposure dwell time 5 minutes

Questions and Answers

Sterilizing Unused Disposable Products

Question: Can I sterilize disposable products?
Answer: Yes, but Cook recommends that you do not sterilize disposable products if any of the following apply:

  • The products have been used
  • The products have been stored beyond the expiration date on the label
  • The products have been exposed to the following hostile environmental storage conditions:
  • Temperatures above 104°F (40°C)
  • Relative humidity above 90%
  • Condensing humidity

Question: Can I sterilize an unused product that has been opened?
Answer: Yes, you can sterilize the product in a validated ethylene oxide sterilization cycle. However, you must first repackage the product according to AAMI-recommended practices.

Question: Can I sterilize an unused disposable product that is packaged nonsterile?
Answer: Yes, you can sterilize the product in a validated ethylene oxide sterilization cycle if the product is in a Tyvek® pouch or in a tray with a sealed Tyvek lid. Otherwise, you must first repackage the product according to AAMI-recommended practices.

Question: What ethylene oxide sterilization cycle should I use for opened-but-unused disposable products and unused nonsterile products?
Answer: Table 1 (above) shows the cycle parameters for sterilizing unused disposable products with EtO. You can sterilize each product only once.

Sterilizing Reusable Products

Question: Can I use EtO to sterilize a reusable Cook product that is in the original package?
Answer: Yes, if the product is packaged in a Tyvek pouch or a tray with a sealed Tyvek lid. With Cook’s other packaging configurations, you must first repackage the product according to AAMI-recommended practices.

Question: Can I put a reusable Cook product that is in its original package through an autoclave cycle?
Answer: No. Original Cook packaging materials for reusable products cannot withstand autoclave cycle parameters.

Question: What is the proper ethylene oxide sterilization cycle for reusable Cook products?
Answer: Cook has validated an ethylene oxide sterilization cycle that can be used in an institutional setting. (See Table 1 above). Before sterilization, you must properly clean and disinfect the product according to the product instructions for use and then package the product according to AAMI-recommended practices (AAMI ST41).

Question: What is the proper autoclave cycle for reusable Cook products?
Answer: Cook has validated an autoclave cycle that can be used in an institutional setting. (See Table 2 above). Before sterilization, you must properly clean and disinfect the product according to the product instructions for use, and then package the product according to AAMI-recommended practices (AAMI SSSA).

Question: Can I use cold disinfectants to disinfect reusable Cook products?
Answer: Yes. Refer to the instructions for use from the manufacturer of the cold disinfectant.

MRI Information

Cook Medical adheres to the MR (magnetic resonance) safety terminology defined in ASTM International standard practice F2503-13. The three categories of MR safety marking are: MR Safe, MR Conditional, and MR Unsafe. In this system, “MR Safe” and “MR Unsafe” are the two extremes. For a device with an “MR Conditional” marking, the item is demonstrated to be safe under defined conditions in the MR environment. The ASTM International document provides corresponding icons that are compact and easily recognized. The terminology and icon structures are intended for use on items that may be brought into or near the MR environment and are intended to help clarify matters related to biomedical implants and devices to ensure the safe use of MRI technology.

Symbol for MR Safe Symbol for MR Safe
This symbol means an item poses no known hazards resulting from exposure to any MR environment. MR Safe items are composed of materials that are electrically nonconductive, nonmetallic, and nonmagnetic.

Symbol for MR Conditional Symbol for MR Conditional
This symbol means an item has demonstrated safety in the MR environment within defined conditions.

Symbol for MR Unsafe Symbol for MR Unsafe
This symbol means an item poses unacceptable risks to the patient, medical staff, or other persons within the MR environment.

Please refer to product labeling or contact Cook Customer Support for specific information about the product’s MR status.

Stainless Steel Embolization Coils

For patients implanted with stainless steel coils, recent testing shows that these coils are MR Conditional.

Nonclinical testing has demonstrated that the standard embolization coil (Stainless Steel) is MR Conditional according to ASTM F2503. A patient with this coil may be scanned safely anytime after placement under the following conditions.

  • Static magnetic field of 3.0 tesla or less
  • Maximum spatial magnetic gradient of 1,600 gauss/cm or less
  • Maximum MR system reported, whole-body-averaged specific absorption rate (SAR) of 2.0 W/kg normal operating mode for 15 minutes of scanning or less (i.e., per scanning sequence)

Static Magnetic Field
The static magnetic field for comparison to the above limits is the static magnetic field that is pertinent to the patient (i.e., outside of scanner covering, accessible to a patient or individual).

MRI-Related Heating
In nonclinical testing, the standard embolization coil (stainless steel) produced a maximum temperature rise of 1.8 °C during 15 minutes of MR imaging (i.e., for one scanning sequence) performed in a MR 3 tesla system (General Electric Excite, Software 14X.M5) at an MR system reported whole-body-averaged SAR of 2.9 W/kg (associated with a calorimetry measured whole-body-averaged value of 2.7 W/kg).

Image Artifact
MR image quality may be compromised if the area of interest is within approximately 75 mm of the position of the standard embolization coil (stainless steel) as found during nonclinical testing using T1-weighted, spin echo and gradient echo pulse sequence in a 3.0 tesla MR system (Excite, General Electric Healthcare, Milwaukee, WI). Therefore, it may be necessary to optimize MR imaging parameters for the presence of this coil.

For U.S. Patients Only

Cook recommends that the patient register the MR conditions disclosed in this IFU with the MedicAlert Foundation. The MedicAlert Foundation can be contacted in the following manners:

MedicAlert Foundation International
2323 Colorado Avenue
Turlock, CA 95382

  • Phone: 888.633.4298 (toll free)
  • Alternate Phone: 209.668.3333 (from outside the U.S.)
Latex Warning

Some Cook product packages have a natural-rubber latex warning. Products that have this warning contain latex that can come into direct or indirect contact with patients or operators during normal use. An example of indirect contact is when a fluid touches the latex and then touches the patient. Please contact Customer Service or your local sales representative if you have further questions.

Item Contains or Has a Presence of Natural Rubber Latex Item Contains or Has a Presence of Natural Rubber Latex
Symbol for an item that contains or has a presence of natural rubber latex. This symbol is used when natural rubber latex is used to make the device or packaging. The symbol is not used for devices containing synthetic rubber. The symbol is intended to warn those who may have allergic reactions to natural rubber latex.

Language Definition
English Item contains or has a presence of natural rubber latex.
České Obsahuje přírodní latex nebo jeho stopy
Dansk Indeholder eller kan indeholde spor af naturgummilatex
Nederlands Bevat natuurlijke rubberlatex of natuurlijke rubberlatex aanwezig
Français Contient du latex de caoutchouc naturel ou présence de latex de caoutchouc naturel
Deutsch Enthält Latex aus Naturkautschuk
Ελληνικά Περιέχεται ή υπάρχει λάτεξ από φυσικό καουτσούκ.
Magyar Összetevőként vagy csomagolásában természetes gumilatexet tartalmaz
Italiano Contiene o presenta tracce di lattice di gomma naturale
日本 天然ゴムラテックスを含む
Norsk Inneholder eller kan inneholde spor av naturgummilateks
Polski Zawartość lub obecność lateksu z kauczuku naturalnego
Português Contém ou está presente látex de borracha natural
Español Contiene o presenta látex de caucho natural
Svensk Innehåller eller förekomst av naturgummilatex
中文 含有或存在天然乳胶
繁體中文 含有或存在天然乳膠成分