Z-0597-2021Class I

Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL1-HC, Order Number G56225 Flexor Introducers and...

Name: Z-0597-2021 Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL1-HC, Order Number G56225 Flexor Introducers and...
Creator: Cook Inc.
Published: 2020-11-24
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2020-11-24 / Terminated / root cause: manufacturing process

FDA source

Cook Inc. began a recall of Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL1-HC, Order Number G56225 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic... on 2020-11-24. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0597-2021
Classification: Class I
Status: Terminated
Initiated: 2020-11-24
Posted: 2020-12-23
Terminated: 2022-09-07
Recalling firm: Cook Incorporated
Product: Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL1-HC, Order Number G56225 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Product code: DYB Introducer, Catheter
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.
Root cause tag: manufacturing process
FDA root 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 ([email protected]). 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: [email protected]. 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: 1262
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.
Product codes and lots: Lot Numbers: 13077814, 13089577, 13105054, 13140910, 13159710, 13162739, 13170661, 13186251, 13192084, 13194969, 13194972, 13200439, 13203160, 13203163, 13203166, 13214447, 13214449, 13217121, 13217122, 13219552, 13223826, 13223829, 13237651, 13276238, 13276245, 13286649, 13357239, 13366218, 13391145, NS13089580, NS13105058, NS13130292, NS13138931, NS13192091, NS13234809, NS13252367, NS13252368, NS13286655, NS13349016, NS13352450, NS13366219, NS13372482, NS13375232, NS13401834, NS13420125

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0597-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0591-2021	Class I	Terminated	Voluntary: Firm initiated	2020-12-30	2020-12-23
Z-0592-2021	Class I	Terminated	Voluntary: Firm initiated	2020-12-30	2020-12-23
Z-0593-2021	Class I	Terminated	Voluntary: Firm initiated	2020-12-30	2020-12-23
Z-0594-2021	Class I	Terminated	Voluntary: Firm initiated	2020-12-30	2020-12-23
Z-0595-2021	Class I	Terminated	Voluntary: Firm initiated	2020-12-30	2020-12-23
Z-0596-2021	Class I	Terminated	Voluntary: Firm initiated	2020-12-30	2020-12-23
Z-0597-2021	Class I	Terminated	Voluntary: Firm initiated	2020-12-30	2020-12-23
Z-0598-2021	Class I	Terminated	Voluntary: Firm initiated	2020-12-30	2020-12-23
Z-0599-2021	Class I	Terminated	Voluntary: Firm initiated	2020-12-30	2020-12-23
Z-0600-2021	Class I	Terminated	Voluntary: Firm initiated	2020-12-30	2020-12-23
Z-0601-2021	Class I	Terminated	Voluntary: Firm initiated	2020-12-30	2020-12-23
Z-0602-2021	Class I	Terminated	Voluntary: Firm initiated	2020-12-30	2020-12-23
Z-0603-2021	Class I	Terminated	Voluntary: Firm initiated	2020-12-30	2020-12-23
Z-0604-2021	Class I	Terminated	Voluntary: Firm initiated	2020-12-30	2020-12-23
Z-0605-2021	Class I	Terminated	Voluntary: Firm initiated	2020-12-30	2020-12-23
Z-0606-2021	Class I	Terminated	Voluntary: Firm initiated	2020-12-30	2020-12-23
Z-0607-2021	Class I	Terminated	Voluntary: Firm initiated	2020-12-30	2020-12-23
Z-0608-2021	Class I	Terminated	Voluntary: Firm initiated	2020-12-30	2020-12-23
Z-0609-2021	Class I	Terminated	Voluntary: Firm initiated	2020-12-30	2020-12-23
Z-0610-2021	Class I	Terminated	Voluntary: Firm initiated	2020-12-30	2020-12-23
Z-0611-2021	Class I	Terminated	Voluntary: Firm initiated	2020-12-30	2020-12-23

Product code DYB

K142829Class IIFlexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor Check-Flo Introducer, Ansel Modification; Flexor Check-Flo Introducers, Ansel Modification with High-Flex Dilator and Hydrophilic Coating; Flexor Check-Flo Introducer Balkin Up and Over Contralateral Design; Flexor Up and Over Balkin Contralateral Introducer; Flexor Check-Flo Introducer, Raabe Modification; Flexor Check-Flo Performer IntroducerCook Incorporated / cleared 2015-07-28

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)