Flexor Check-Flo Introducers and Sets, Reference Part Numbers: 1) KCFW-9.0-18/38-45-RB-ANL0-HC; 2) KCFW-9.0-18/38-45-RB-
FDA device recall Z-0993-2026 · posted 2025-12-23 · Open, Classified
Recall details
- Recalling firm
- Cook Incorporated
- Reason for recall
- Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly.
- Action taken
- Cook Medical issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 11/26/2025 by email and/or letter delivered via a courier. The notice explained the issue, risk to health, and requested the identification and return of the affected product. The notice must be shared with appropriate personnel, including down to the user level, within your organization or with any organization where the affected devices have been transferred. For questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- DYB
- Quantity affected
- 7952 units
- Distribution
- Worldwide distribution.
- Date initiated
- 2025-11-26
- Date posted
- 2025-12-23
- Location
- Bloomington, IN
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