Z-2539-2017Class II

Cook Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages

Name: Z-2539-2017 Cook Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages
Creator: Cook Inc.
Published: 2017-05-09
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2017-05-09 / Terminated / root cause: design

FDA source

Cook Inc. began a recall of Cook Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages on 2017-05-09. FDA classified it as Class II and gives the reason as "Correction to the product Instructions for Use because the current reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2539-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-09
Posted: 2017-06-05
Terminated: 2018-01-26
Recalling firm: Cook Incorporated
Product: Cook Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages
Product code: GEX Powered Laser Surgical Instrument
Reason for recall: Correction to the product Instructions for Use because the current reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products.
Root cause tag: design
FDA root cause: Device Design
Action: Cook is initiating a voluntary recall of multiple products in the form of a correction to the product Instructions for Use. Cook Inc. has identified the current reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products. Potential adverse events that may occur if the products are not adequately reprocessed include urological infections and systemic infections from a urological origin as well as events resulting from chemical residual exposure. Cook distributed notices via courier on May 9, 2017. Customers were instructed to do the following: Distribution of the Cook Multi-Use Holmium Laser Fibers will not occur until the reprocessing instructions in the Instructions for Use have been corrected. Single use fibers are available. Contact your local sales representative for further information. You can continue to use your inventory of Cook Multi-Use Holmium Laser Fibers by following the attached Suggested Fiber Reprocessing Instructions. Action to be taken: 1. Examine your inventory immediately to identify and quarantine those affected products. 2. Implement the updated Suggested Fiber Reprocessing Instructions. 3. Return the required Acknowledgement and Receipt Form within 30 days. 4. Even if you do not have affected products, you must still complete the Acknowledgement and Receipt Form and send it via fax (812.339.7316) or email ([email protected]). 5. Immediately report any adverse events to Cook Medical Customer Relations at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30 am and 5:00 pm (Eastern Time), or by email at [email protected]. Adverse events or quality problems experienced with the use of this product may also be reported to the FDA: Online at: http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm (form available to fax or mail) Call the FDA at: 1-800-FDA-1088 Should you have any medical questions or concer
Quantity in commerce: 4369
Distribution: Domestic: AL AR AZ CA CO FL GA HI ID IL IN KY LA MD MI MO MS NC NM NY OH OK OR PA SC TN TX UT VA WA WI Foreign: Austria, Australia, Argentina, Azerbaijan, Belgium, Bulgaria, Bahrain, Canada, Chile, China, Cyprus, Czech Republic, Denmark, Djibouti, Egypt, France, Hong Kong, Honduras, Croatia, Greece, Germany, Hungary, India, Ireland, Italy, Latvia, Malaysia, Morocco, Netherlands, Poland, Portugal, Puerto Rico, Saudi Arabia, Serbia, Spain, Slovenia, South Africa, Sri Lanka, Sweden, Singapore, Taiwan, Thailand, Tunisia, United Kingdom, and Uruguay
Product codes and lots: HLF-M273-H30 HLF-M365-H30 HLF-M550-H30 HLF-M940-H30 HLF-M273-HSMA HLF-M365-HSMA HLF-M550-HSMA HLF-M940-HSMA

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2539-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2539-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-14

Product code GEX

K124030Class IICook Holmium Laser FiberCook Incorporated / cleared 2013-07-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)