Z-0185-2022Class II
Flexor Check-Flo Introducer, Introducer Set, RPN KCFW-6.0-35-45-RB, GPN G09908 The introducer sheath...
Cook Incorporated / initiated 2021-09-28 / Terminated / root cause: manufacturing process
Cook Inc. began a recall of Flexor Check-Flo Introducer, Introducer Set, RPN KCFW-6.0-35-45-RB, GPN G09908 The introducer sheath incorporates a hydrophilic coated Flexor shaft with a... on . 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 , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-0185-2022
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Cook Incorporated
- Product
- Flexor Check-Flo Introducer, Introducer Set, RPN KCFW-6.0-35-45-RB, GPN G09908 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 (OUS)
- 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 13861362
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0185-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0186-2022 | Class II | Terminated | Voluntary: Firm initiated |
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