Class 2 Device Recall Spectrum Central Venous Catheter Tray

• Date Initiated by Firm: March 06, 2020
• Create Date: March 24, 2020
• Recall Status: Terminated on December 18, 2020
• Recall Number: Z-1566-2020
• Recall Event ID: 85187
• 510(K)Number: K033843
• Product Classification: Catheter, intravascular, therapeutic, short-term less than 30 days - Product Code FOZ
• Product: Spectrum Central Venous Catheter Tray, Irrigation Catheter, Reference Part Number C-UDLMY-401 J-ABRM-HC-IHl-FST, Order Number G48053
• Code Information: Lot Number 10235662; UDI: (01)00827002480537(17)562310(10)10235662
• Recalling Firm/ Manufacturer: Cook Inc.; 750 N Daniels Way; Bloomington IN 47404-9120
• For Additional Information Contact: Cook Medical Customer Relations Department; 812-339-2235
• Manufacturer Reason for Recall: The printed expiration dates are incorrect.
• FDA Determined Cause: Under Investigation by firm
• Action: An Urgent Medical Device Recall notification letter dated 3/6/2020 was distributed to customers. Actions to be Taken by the Customer 1.Examine inventory immediately to determine if you have affected product(s) and quarantine anyaffected product that remains unused. Immediately cease all distribution and use of this product. 2.Return the affected product(s) to Cook Medical with a copy of the Acknowledgement andReceipt Form to receive a product credit. Refer to the Acknowledgement and Receipt Form forreturn instructions. Note: Unaffected products that are returned will not be credited. 3.Please complete the Acknowledgement and Receipt Form within 5 business days of receivingthis letter. Even if you do not have affected product(s) on hand, you must still complete theAcknowledgement and Receipt Form and return via fax (812.339.7316) or email(FieldActionsNA@CookMedical.com). 4.This notice must be shared with appropriate personnel, including down to the user level, withinyour organization or with any organization where the potentially affected devices have beentransferred. 5.Immediately report adverse events to Cook Medical Customer Relations by phone at800.457.4500 or 812.339.2235, Monday through Friday between 7:30am and 5:00pm (EasternTime), or by email to: CustomerRelationsNA@CookMedical.com.
• Quantity in Commerce: 25
• Distribution: The products were distributed to the following US states: CO, DE, MD, MN, NC, NV, and WV. The products were distributed to the following foreign countries: Canada.
• 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