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U.S. Department of Health and Human Services

Class 2 Device Recall Cook Spectrum

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  Class 2 Device Recall Cook Spectrum see related information
Date Initiated by Firm November 28, 2016
Date Posted December 12, 2016
Recall Status1 Terminated 3 on September 06, 2017
Recall Number Z-0733-2017
Recall Event ID 75793
510(K)Number K033843  
Product Classification Catheter,intravascular,therapeutic,short-term less than 30 days - Product Code FOZ
Product Cook Spectrum Minocycline/Rifampin Impregnated Double Lumen Central Venous Catheter Tray
Cook Spectrum Minocycline/Rifampin Impregnated Triple Lumen Central Venous Catheter Tray
Code Information catalog number: C-UDLMY-401J-ABRM-HC-FST Lot 6498570 catalog number: C-UTLMY-501J-ABRM-HC-FST Lot 6501835  Exp date 9/30/2018
Recalling Firm/
Manufacturer		 Cook Inc.
750 N Daniels Way
Bloomington IN 47404-9120
For Additional Information Contact Cook Medical Customer Relations Departme
800-457-4500
Manufacturer Reason
for Recall		 Cook Medical has received reports of the trays containing the incorrect needle, which in some cases could result in the inability to pass a wire guide through the needle. Potential adverse events that may occur as a result of utilizing needles of incorrect size include delay in treatment, which could be critical in an emergent situation. There have been no reports of illness or injury associated with this issue.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action Cook Medical sent an Urgent - Medical Device Recall letter dated November 23, 2016. to all affected customers. The letter identified the product the problem and the action needed to be taken. Action to be taken: 1. Please review the attached list of affected products and lot numbers that were shipped to your account and quarantine any affected products that remain unused. 2. Immediately collect and return all unused affected products to Cook Medical as soon as possible for credit. 3. Please complete the attached Acknowledgement and Receipt Form and return it to Cook Medical. 4. Please report any adverse event to Cook Medical Customer Relations at (800) 457-4500 or 1(812) 339-2235, Monday through Friday between 7:30 am and 5:00 pm Eastern Standard Time or e-mail at fieldactionsna@cookmedical.com. Transmission of this notice: This notice must be passed on to appropriate personnel, including down to the user level, within your organization or to any organization where the potentially affected devices have been transferred. Should you have any questions or concerns, please do not hesitate to contact Cook Medical Customer Relations at (800) 457-4500 or 1(812) 339-2235.
Quantity in Commerce 99 units
Distribution AZ CA DC GA IL LA MN MS NC NV NY OK PA TN TX WI
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FOZ and Original Applicant = COOK, INC.
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