Z-0186-2022Class II

Flexor Check-Flo Introducer - Raabe Modification, Introducer Set, RPN KCFW-5.0-38-90-RB-RAABE, GPN G13069 The...

Name: Z-0186-2022 Flexor Check-Flo Introducer - Raabe Modification, Introducer Set, RPN KCFW-5.0-38-90-RB-RAABE, GPN G13069 The...
Creator: Cook Inc.
Published: 2021-09-28
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2021-09-28 / Terminated / root cause: manufacturing process

FDA source

Cook Inc. began a recall of Flexor Check-Flo Introducer - Raabe Modification, Introducer Set, RPN KCFW-5.0-38-90-RB-RAABE, GPN G13069 The introducer sheath incorporates a hydrophilic... on 2021-09-28. FDA classified it as Class II and gives the reason as "Affected lots may be manufactured incorrectly with the radiopaque marker band located just below the Check-Flo proximal fitting instead of the distal tip. The issue may not be identified until the device is placed in...". 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-0186-2022
Classification: Class II
Status: Terminated
Initiated: 2021-09-28
Posted: 2021-10-29
Terminated: 2024-02-28
Recalling firm: Cook Incorporated
Product: Flexor Check-Flo Introducer - Raabe Modification, Introducer Set, RPN KCFW-5.0-38-90-RB-RAABE, GPN G13069 The introducer sheath incorporates a hydrophilic coated Flexor shaft with a hemostasis valve and is provided with a dilator.
Product code: DYB Introducer, Catheter
Reason for recall: Affected lots may be manufactured incorrectly with the radiopaque marker band located just below the Check-Flo proximal fitting instead of the distal tip. The issue may not be identified until the device is placed in the patient and viewed under fluoroscopy, leading to increased procedural time.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: On September 28, 2021, the firm distributed Urgent Medical Device Recall letters to affected customers. Customers should 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 to the firm. 4. This notice 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]. Cook Medical is removing potentially impacted devices from the market. Additionally, an investigation has been opened to determine the appropriate corrective action(s) to prevent reoccurrence of a similar issue.
Quantity in commerce: 48 (US)
Distribution: Domestic distribution to AR AZ CT FL GA IL LA MA ME MN ND NJ NY OH PA TX WA. Foreign distribution to Germany, Finland, Italy, Netherlands, and Switzerland.
Product codes and lots: lot 13846597

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0186-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0185-2022	Class II	Terminated	Voluntary: Firm initiated	2021-11-10	2021-10-29
Z-0186-2022	Class II	Terminated	Voluntary: Firm initiated	2021-11-10	2021-10-29

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)