Food, drugs, devices › Cook Inc.
Device recall: Fixed Core Wire Guide, RPN TSCF-35-260-3, GPN G00517. The product is a curved wire guide with PTFE coating manufactured
FDA enforcement event 86642 is a device recall by Cook Inc. of Bloomington, IN, initiated 22 Oct 2020 and classified Class I, with 1 product record.
FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 4% of the 916 device enforcement events initiated in 2020 carry the same class.
Status: Terminated, terminated 2 Sep 2021. 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 product was dropped during manufacturing, which may result in a bent wire guide and/or the presence of loose foreign matter on the wire guide."
Distribution
"US distribution to AZ, IA, IN, MA, and ND."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0399-2021 | Fixed Core Wire Guide, RPN TSCF-35-260-3, GPN G00517. The product is a curved wire guide with PTFE coating manufactured from stainless steel. To assist in inserting catheters, introducer sheaths, and other medical devices in vascular applications. | 61 units | Class I | Terminated | 11 Nov 2020 |
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 product was dropped during manufacturing, which may result in a bent wire guide and/or the presence of loose foreign matter on the wire guide."
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Where was the product distributed?
FDA's distribution pattern field reads: "US distribution to AZ, IA, IN, MA, and ND."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 2 Sep 2021. "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.