Food, drugs, devices › Cook Inc.
Device recall: Flexor Check-Flo Introducer, Introducer Set, RPN KCFW-6.0-35-45-RB, GPN G09908 The introducer sheath incorporates a hydr
FDA enforcement event 88787 is a device recall by Cook Inc. of Bloomington, IN, initiated 28 Sep 2021 and classified Class II, with 2 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 89% of the 900 device enforcement events initiated in 2021 carry the same class.
Status: Terminated, terminated 28 Feb 2024. Initiation: voluntary: firm initiated. Cook Inc. has 61 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Cook Inc., Bloomington, IN.
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."
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 records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0185-2022 | 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. | 48 (OUS) | Class II | Terminated | 10 Nov 2021 |
| Z-0186-2022 | 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. | 48 (US) | Class II | Terminated | 10 Nov 2021 |
Context
Other enforcement events for Cook Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall 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 the patient and viewed under fluoroscopy, leading to increased procedural time."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "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."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 28 Feb 2024. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.