Class 1 Device Recall Flexor CheckFlo Introducer

• Date Initiated by Firm: November 24, 2020
• Date Posted: December 23, 2020
• Recall Status: Terminated on September 07, 2022
• Recall Number: Z-0594-2021
• Recall Event ID: 86804
• 510(K)Number: K142829
• Product Classification: Introducer, catheter - Product Code DYB
• Product: Flexor Check-Flo Introducer, RPN KCFW-5.0-35-55-RB-HFANL0-HC, Order Number G56230; ; Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
• Code Information: Lot Numbers: 13029693, 13029694, 13039738, 13039739, 13094338, 13094339, 13094340, 13094344, 13112923, 13112926, 13112927, 13119643, 13121403, 13124432, 13124433, 13126447, 13126448, 13126462, 13135821, 13135822, 13138934, 13138941, 13143088, 13143089, 13143090, 13145948, 13145949, 13153368, 13155283, 13158193, 13158194, 13158195, 13159695, 13163184, 13172666, 13172667, 13172668, 13189166, 13189167, 13189168, 13189171, 13194980, 13197476, 13197477, 13197478, 13197479, 13197480, 13202941, 13202942, 13202943, 13202944, 13202945, 13202946, 13202947, 13202948, 13202949, 13202950, 13202951, 13202953, 13207444, 13207445, 13207446, 13207447, 13207448, 13207449, 13207450, 13207451, 13207452, 13207453, 13207454, 13207455, 13207456, 13207457, 13207458, 13262315, 13262317, 13262321, 13265318, 13268024, 13268028, 13268030, 13268031, 13276235, 13276239, 13276242, 13279088, 13279105, 13281543, 13281544, 13288125, 13291883, 13301861, 13304456, 13318043, 13323500, 13323501, 13337799, 13337809, 13346109, 13352474, 13354244, 13357252, 13363227, 13366216, 13372480, 13391143, NS13108032
• Recalling Firm/ Manufacturer: Cook Inc.; 750 N Daniels Way; Bloomington IN 47404-9120
• Manufacturer Reason for Recall: There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage.
• FDA Determined Cause: Process control
• Action: The firm, Cook Medical, sent "URGENT: MEDICAL DEVICE RECALL" letters dated 11/24/20 to customers. The letter described the product, problem and actions to be taken. The customers were instructed to take the following actions: 1. Examine inventory immediately to determine if you have affected product(s) and quarantine any affected 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 and Receipt Form to receive a product credit. Refer to the Acknowledgement and Receipt Form for return instructions. Note: Unaffected products that are returned will not be credited. 3. Please complete the Acknowledgement and Receipt Form within 5 business days of receiving this letter. Even if you do not have affected product(s) on hand, you must still complete the Acknowledgement and Receipt Form and return via fax (812.339.7316) or email (FieldActionsNA@CookMedical.com). 4. This medical device recall letter must be shared with appropriate personnel, including down to the user level, within your organization or with any organization where the potentially affected devices have been transferred. 5. Immediately report adverse events to Cook Medical Customer Relations by phone at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30am and 5:00pm (Eastern Time), or by email to: CustomerRelationsNA@CookMedical.com. Action being Taken by Cook Medical Cook Medical is removing devices potentially impacted from the market. Additionally, an investigation has been opened to determine the appropriate corrective action(s) to prevent reoccurrence of a similar issue. Other Information This action is being taken with the knowledge of the Food and Drug Administration. Adverse events or quality problems experienced with the use of this product may also be reported to the FDA: " Visit http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm to obtain a form to
• Quantity in Commerce: 4767
• Distribution: US Nationwide Distribution including states of: AK, CT, IA, LA, MO, NH, OK, TN, WI, AL, DC, ID, MA, MS, NJ, OR, TX, WV, AR, DE, IL, MD, MT, NM, PA, UT, WY, AZ, FL, IN, ME, NC, NV, RI, VA, CA, GA, KS, MI, ND, NY, SC, VT, CO, HI, KY, MN, NE, OH, SD, WA and Global Distribution to: AU, SG, Austria, Belgium, Canary Islands, CN, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Italy, KR, Latvia, Lithuania, MY, Morocco, Netherlands, Norway, Poland, Portugal, Reunion, Russian Federation, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, TW, TH, and United Arabs Emirates.
• 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 = DYB and Original Applicant = Cook Incorporated